[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-subdural-hematoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-subdural-hematoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,78,105,130,157,185,210,233,259,287,315,338,372,399,420,444,472,497,523,549,572],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100468046","efficacy-of-a-minimally-invasive-therapy-adjuvant-to-the-standards-of-care-by-cyanoacrylate-embolization-100468046",false,"NCT05374681","Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization","LEADH: Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization : Liquid Embolic Agent for the Treatment of Chronic subDural Hematoma a Randomized Control Study","LEADH","Inclusion Criteria:\n\n* Patient with a more than 10 mm CSH confirmed by NCCT\n* CSH localized to convexity\n* Patient aged 18 years or more at the time of the enrollment\n* Patient beneficiary from health insurance\n\nExclusion Criteria:\n\n* Any contraindication as required per angiogram procedure (severe renal failure ≥ 4, allergy…)\n* Pre-existing severe disability resulting in baseline mRS score \\> 3\n* Life expectancy of less than 6 months due to another cause than CSH\n* Patient under legal protection or deprived of liberty by a judicial or administrative decision\n* Pregnant or breastfeeding women\n* Vulnerable persons unable to give consent","ALL","18 Years",{"count":20,"type":21},550,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and\u002For surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose.\n\nPreliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.\n\nThe investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.",[27],"Chronic Subdural Hematoma",[29,30,31,32],"Cyanoacrylate","Embolization","Middle meningeal artery","Recurrence of chronic subdural hematoma","RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2023-03-28",{"date":41,"type":21},"2028-09-28",{"name":43,"class":44},"University Hospital, Brest","OTHER",11,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100641148","non-thermal-plasma-to-reduce-recurrence-in-chronic-subdural-hematoma-100641148","NCT07656818","Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma","Application of Non-Thermal Plasma in the Surgical Bed of Chronic Subdural Hematoma to Reduce the Post-Drainage Recurrence Rate: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Diagnosis of symptomatic chronic subdural hematoma (cSDH) requiring surgical drainage (burr hole drainage or craniotomy)\n* Ability to provide written informed consent (or consent from legal representative if patient is incapacitated)\n\nExclusion Criteria:\n\n* Pure acute or subacute subdural hematoma\n* Uncontrolled coagulopathy or bleeding disorder\n* History of intracranial aneurysm or prior cerebrovascular event with residual deficit\n* Presence of active intracranial metallic implants or electronic devices (e.g., programmable shunt, cardiac pacemaker, deep brain stimulator) in the head region\n* Pregnancy or lactation\n* Participation in another interventional clinical trial within 30 days prior to screening",{"count":54,"type":21},40,[24],"The goal of this randomized controlled trial is to evaluate whether the adjuvant application of non-thermal plasma (NTP) during standard surgical drainage of chronic subdural hematoma (cSDH) can reduce the recurrence rate at 6 months. The main questions it aims to answer are:\n\n* Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone?\n* Is NTP safe when applied to the subdural space and surgical wound bed?\n* Does NTP improve functional outcomes and time to hematoma resolution?\n\nParticipants will be randomly assigned to one of two groups:\n\n* Experimental group (n = 20): Standard burr hole drainage or craniotomy plus intraoperative NTP application over the exposed dura mater, the residual membrane, soft tissue layers, and the skin incision.\n* Control group (n = 20): Standard surgical drainage alone (no NTP).\n\nFollow-up includes clinical assessments and computed tomography (CT) scans at 1 week, 3 months, and 6 months post-surgery. The primary outcome is recurrence (symptomatic reaccumulation requiring re-intervention or ≥50% volume increase on CT).",[27,58,59,60],"Subdural Hematoma","Recurrence","Postoperative Complications",[62,63,64,65,66,67],"Non-thermal plasma","Cold plasma","Chronic subdural hematoma","Neurosurgery","Recurrence prevention","Wound healing","2026-06-16",{"date":70,"type":37},"2026-06-18",{"date":72,"type":37},"2026-03-02",{"date":74,"type":21},"2027-04-30",{"name":76,"class":44},"Benjamín Gonzalo Rodríguez Méndez",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100542817","chronic-subdural-hematoma-treatment-with-embolization-versus-surgery-study-100542817","NCT06347796","Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study","CHESS","Inclusion Criteria:\n\n1. Age 40-90 years inclusively.\n2. Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment (at least 10 mm in thickness) and the contralateral side is asymptomatic and \\\u003C 10 mm in thickness.\n3. CSDH at least 2\u002F3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.\n4. Qualifying baseline head CT performed within the 7 days prior to randomization.\n5. Able to undergo assigned treatment within 72 hours after randomization.\n6. Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.\n\nExclusion Criteria:\n\n1. Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.\n2. Tentorial or interhemispheric SDH.\n3. Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.\n4. Pre CSDH mRS of 5 or higher.\n5. Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG \\> 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for reason other than CSDH.\n6. Secondary to CSDH, ASR of 0, 1, or 2.\n7. Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.\n8. Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.\n9. Indication that withdrawal of care will be implemented for the qualifying SDH.\n10. Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.\n11. On tranexamic acid.\n12. Platelet count of \\\u003C100,000 per microliter refractory to transfusion.\n13. Coagulopathy that cannot be corrected to an INR of ≤1.5.\n14. Known contraindications to angiography.\n15. Known intolerance to occlusion procedures.\n16. Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection.\n17. Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.\n18. Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial\u002Fcapillary\u002Fvenous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.\n19. Patient has a known active systemic infection or sepsis.\n20. Patient is pregnant, planning to become pregnant, or lactating.\n21. Life expectancy of less than 6 months due to comorbid terminal conditions.\n22. Concurrent participation in another research protocol for investigation of an experimental therapy.\n23. Known or suspected to not be able to comply with the study protocol.\n24. For unilateral CSDH, no measurable deficit secondary to the CSDH on the Timed Up and Go \\[TUG\\], Aphasia Severity Rating \\[ASR\\], or MRC. At baseline, a measurable deficit on the TUG is defined as: time ≥10 seconds. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score \\\u003C 5 in any muscle group contralateral to the site of the CSDH.\n25. For bilateral CSDH, no measurable deficit secondary to the treatment-eligible CSDH on the ASR or MRC. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score \\\u003C 5 in any muscle group contralateral to the treatment-eligibile CSDH side.","40 Years","90 Years",{"count":88,"type":21},520,[24],"The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:\n\n* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?\n* What is the safety of MMAE and conventional open surgery in these patients?\n\nParticipants will be asked to:\n\n* Share their medical history and undergo physical examinations\n* Have blood drawn\n* Have CT scans of the head\n* Answer questionnaires\n* Undergo MMAE or conventional open surgery\n* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.",[27],[93,94],"chronic subdural hematoma (CSDH)","middle meningeal artery embolization (MMAE)","2026-05-19",{"date":97,"type":37},"2026-05-22",{"date":99,"type":37},"2024-11-01",{"date":101,"type":21},"2029-02",{"name":103,"class":44},"The University of Texas Medical Branch, Galveston",31,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":77},"100546961","the-effectiveness-and-safety-of-body-posture-in-preventing-postoperative-recurrence-for-chronic-subdural-hematoma-100546961","NCT06401772","The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma","The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. chronic subdural hematoma is diagnosed with CT\u002FMRI scan; thickness of hematoma is more than 1 cm;\n2. more than 60 years of age or 60 years;\n3. MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;\n4. patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.\n5. receive burr hole drainage;\n6. sign informed consent voluntarily.\n\nExclusion Criteria:\n\n1. have brain hernia or acute massive cerebral infarction that have to perform craniotomy\n2. have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;\n3. Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence\n4. Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.\n5. Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by neurosurgeons;\n6. CSDH persisting for over 1 year and exhibiting marked organization\u002Fsolidification of the hematoma;\n7. CSDH caused by over V-P shunting;\n8. during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;\n9. Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;\n10. have deep venous thrombosis of lower extremity or pulmonary embolism;\n11. cannot complete regular reexamine within 1 year for any reason;\n12. life expectancy less than 1 year;\n13. participating other ongoing clinical trial;\n14. patients are not qualified for other reason evaluated by two neurosurgeons;\n15. have bile reflux gastritis and esophageal diseases.","60 Years",{"count":114,"type":21},830,[24],"This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma",[27,59],[27,119,120],"body posture","intracranial pressure","2026-04-26",{"date":123,"type":37},"2026-04-30",{"date":125,"type":37},"2024-08-08",{"date":127,"type":21},"2028-01",{"name":129,"class":44},"Huashan Hospital",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":140,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":77},"100625347","implementation-of-an-enhanced-recovery-pathway-for-burr-hole-drainage-in-patients-with-a-chronic-subdural-hematoma-100625347","NCT07421453","Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma","Enhanced Recovery Pathway for Chronic Subdural Hematoma","ERP-cSDH","Inclusion Criteria:\n\n* Age 18 years or older\n* Existence of a chronic subdural hematoma requiring burr-hole drainage\n* Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.\n\nExclusion Criteria:\n\n* Existence of an important underlying cerebral lesion (e.g. a vascular lesion, tumor)\n* History of treatment (surgical or by middle meningeal artery embolization) of a same sided cSDH",{"count":139,"type":21},150,"6 Months","OBSERVATIONAL","A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.",[27,144],"Chronic Subdural Hematomas",[64,146,147],"Burr-hole drainage","Enhanced recovery protocol","2026-02-16",{"date":150,"type":37},"2026-02-19",{"date":152,"type":37},"2024-12-23",{"date":154,"type":21},"2028-07-31",{"name":156,"class":44},"Universitaire Ziekenhuizen KU Leuven",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100604046","neuroendoscopy-assisted-drainage-versus-burr-hole-drainage-for-chronic-subdural-hematoma-100604046","NCT07144423","Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma","Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial, URANUS","URANUS","Inclusion Criteria:\n\n1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.\n2. CSDH verified on cranial computed tomography or magnetic resonance imaging.\n3. Written informed consent from patients or their next of kin according to the patient's cognitive status.\n\nExclusion Criteria:\n\n1. No clinical symptoms correlating with chronic subdural hematoma.\n2. Lack of mass effect and midline shift \\\u003C 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.\n3. Previous surgery for CSDH during the past 6 months.\n4. Previous intracranial surgery for any other neurological disorder.\n5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed.\n6. Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \\> 3.0; absolute platelet count \\\u003C 100×109\u002FL).\n7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit.\n8. Reproductive-age women without verified negative pregnancy testing.\n9. Participating in another research.",{"count":166,"type":21},770,[24],"Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.",[27],[27,171,172,173,174],"Neuroendoscopy-assisted Drainage","Burr Hole Drainage","Recurrence Rate","Neurological Outcome","2026-02-05",{"date":177,"type":37},"2026-02-09",{"date":179,"type":37},"2025-11-19",{"date":181,"type":21},"2027-12-31",{"name":183,"class":44},"Beijing Tiantan Hospital",24,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100530070","middle-meningeal-artery-embolization-mmae-outcomes-for-chronic-subdural-hematoma-csdh-100530070","NCT06181994","Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)","Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)","MESH","Inclusion Criteria:\n\n* Consecutive adult patients (18 yrs. of age or older)\n* Endovascular embolization of middle meningeal artery using any embolization material:\n\nPVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils\n\nExclusion Criteria:\n\n* Endovascular embolization of middle meningeal artery using any other embolization material",{"count":194,"type":21},5000,"This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.",[27],[198,199],"Middle meningeal artery embolization","Endovascular Embolization","2026-01-05",{"date":202,"type":37},"2026-01-07",{"date":204,"type":37},"2023-12-05",{"date":206,"type":21},"2026-08",{"name":208,"class":44},"Montefiore Medical Center",19,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":77},"100617894","microfabricated-microcatheter-advantages-in-middle-meningeal-artery-embolization-an-early-experience-at-a-single-center-100617894","NCT07324551","Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center","SCIENTIA","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patient or legally authorized representative (LAR) signs an informed consent form\n* Confirmed diagnosis of subacute or chronic subdural hematoma, defined as 50% or more chronic blood\n* Pre-morbid Modified Rankin Score of ≤ 3\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization\n* Unmanaged, uncontrolled bleeding disorders\u002Fblood diathesis\n* Presumed septic embolus, or suspicion of microbial superinfection\n* Contraindication to angiography\n* CT or MRI evidence of intra-cranial tumor or mass lesion",{"count":218,"type":21},100,"The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference",[27,221],"Hemorrhage Brain",[223,224,27],"MMA Embolization","cSDH","2025-12-23",{"date":202,"type":37},{"date":228,"type":37},"2025-11-03",{"date":230,"type":21},"2029-07-01",{"name":232,"class":44},"Ohio State University",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":77},"100611798","phase-2-adjuvant-tranexamic-acid-txa-versus-surgery-alone-for-adult-patients-with-chronic-subdural-hematoma-csdh-100611798","NCT07245264","Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)","Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma","RATATA","Inclusion Criteria:\n\n1. Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.\n2. Adult patient ≥18 years\n3. Scheduled for single or double burr hole for evacuation.\n4. No contraindication for TXA\n\nExclusion criteria\n\n1. Mechanical heart valve\n2. Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment\n3. Intracranial surgery within last 6 months\n4. Pregnancy and woman\\\u003C40 years\n5. Participation in any other clinical trial\n6. Life expectancy of less than one year.\n7. A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 \\[no symptoms\\] to 6 \\[death\\]) before the hematoma occurred.\n8. Unfit for participations for any other reason as evaluated by the including physician.\n9. History of severe impairment of renal function (eGFR \\\u003C30ml\u002Fmin or serum creatinine \\>150μmol\u002FL)\n10. Known hypersensitivity or allergy to TXA\n11. Inability to obtain informed consent from the patient or legal representative",{"count":242,"type":21},274,[244,245],"PHASE2","PHASE3","This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.",[27],[64,249,65],"Tranexamic acid","2025-12-01",{"date":252,"type":37},"2025-12-08",{"date":254,"type":21},"2025-12-10",{"date":256,"type":21},"2029-06-01",{"name":258,"class":44},"St. Olavs Hospital",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100563841","a-national-study-examining-the-most-effective-drainage-method-after-burr-hole-evacuation-of-chronic-subdural-hematoma-100563841","NCT06621407","A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma","Active 24 Hours Subperiostal vs. 24 Hours Passive Subdural Drainage Following Burr Hole Evacuation of Chronic Subdural Hematoma (the SUPERDURA Trial) - Protocol for a Nationwide Randomized Clinical Non-inferiority Trial","SUPERDURA","Inclusion Criteria:\n\n* Adult patients (≥ 18 years).\n* Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment.\n* Patients undergoing a single burr-hole evacuation.\n* Informed written and oral consent is taken prior to surgery.\n\nExclusion Criteria:\n\n* Patients who are mentally incapacitated\n* Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type)\n* Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt.\n* Patients with additional\u002Fpreviously intracranial pathology that requires\u002Fhas required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess).\n* Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason)\n* Patients unable to give consent prior to surgery",{"count":268,"type":21},354,[24],"Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking.\n\nThe aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH.\n\nThe study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark.\n\nAdult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides.\n\nBefore surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage.\n\nThe patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence.\n\nSecondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures.\n\nSample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years.\n\nEthics approval for inclusion of competent patients has been obtained (N-20240009).",[27,272,59,273,274,275,276],"Surgical Procedures, Operative","Mortality","Drainage","Drainage\u002FMethods","Drainage Procedure","2025-11-20",{"date":279,"type":37},"2025-11-25",{"date":281,"type":37},"2025-09-01",{"date":283,"type":21},"2027-11",{"name":285,"class":44},"Aalborg University Hospital",4,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100611428","aspirin-continuation-or-discontinuation-in-conservative-treatment-for-chronic-subdural-hematoma-100611428","NCT07240454","Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma","Safety and Efficacy of Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age ≥18 years, male or female;\n* Confirmed diagnosis of chronic subdural hematoma (cSDH) by cranial CT and\u002For MRI;\n* Intended for conservative management (i.e., no surgical evacuation indication at enrollment);\n* Regular aspirin use at enrollment;\n* Informed consent signed by the patient or legal representative.\n\nExclusion Criteria:\n\n* Patients requiring emergency surgery to remove hematoma at enrollment;\n* Concurrent use of other anticoagulants or antiplatelet agents that cannot be discontinued according to the study protocol;\n* cSDH secondary to other diseases or conditions (e.g., excessive drainage from ventriculoperitoneal shunts, intracranial tumors);\n* Active bleeding events or major cardiac events (e.g., acute myocardial infarction, unstable angina, or revascularization surgery) within 30 days prior to enrollment;\n* Known bleeding disorders (e.g., hemophilia, severe thrombocytopenia);\n* Individuals unable to provide informed consent or for whom completion of follow-up is anticipated to be difficult.",{"count":295,"type":21},143,[24],"This clinical study aims to learn about the efficacy and safety of aspirin continuation or discontinuation in conservative treatment for chronic subdural hematoma. All participants received standard conservative treatment for chronic subdural hematoma, with a randomized intervention to either continue or discontinue aspirin administration. By participating in this study, participants can receive additional scientific guidance on aspirin medication management beyond routine conservative treatment, thereby optimizing individualized therapy.",[27],[27,300,301,302,303,304,224],"Aspirin","Conservative Treatment","Randomized Clinical Trial","Safety","Efficacy","2025-11-16",{"date":307,"type":37},"2025-11-21",{"date":309,"type":37},"2025-10-15",{"date":311,"type":21},"2028-12",{"name":313,"class":44},"Tao Liu",2,{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":140,"studyType":141,"phases":4,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":327,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":314},"100609441","prospective-multi-center-single-arm-study-for-subjects-with-chronic-subdural-hematoma-treated-with-i-ed-coils-either-alone-or-in-combination-with-burr-holes-or-mini-craniotomy-100609441","NCT07214623","Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy","i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study","iCURE cSDH","Inclusion Criteria:\n\n* Pre morbid mRS 0-3\n* Chronic subdural symptomatic, requiring intervention\n\nExclusion Criteria:\n\n* Acute subdural hematoma\n* Intercranial mass other than subdural hematoma\n* Females pregnant or breast feeding\n* Compromised survival or inability to complete trial",{"count":324,"type":21},200,"All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.",[27,224,144],"NOT_YET_RECRUITING","2025-10-02",{"date":330,"type":37},"2025-10-09",{"date":332,"type":21},"2025-11-30",{"date":334,"type":21},"2027-05-31",{"name":336,"class":337},"Kaneka Medical America LLC","INDUSTRY",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100569579","restarting-early-versus-later-anticoagulation-for-chronic-subdural-hematoma-with-atrial-fibrillation-100569579","NCT06696079","Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation","Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial","RELACS","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation with drainage (CSDH is predominantly hypodense or isodense on imaging \\[CT\u002FMRI\\]; clinical symptoms attributable to the CSDH; patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant).\n* Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known\n* Randomization done within 4 days of the surgery\n\nExclusion Criteria:\n\n* Intraoperative or immediate postoperative hemorrhagic complication\n* CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)\n* Prior CSDH surgery within 12 months\n* Cerebrospinal fluid shunt\n* CSDH is in an arachnoid cyst\n* If the operated hematoma is revealed to be a cerebrospinal fluid collection (hygroma)\n* Conditions other than atrial fibrillation that require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)\n* Mechanical heart valve(s)\n* Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)\n* Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall \\[e.g. due to severe alcoholism\\], severe thrombocytopenia, severe anemia)\n* Concomitant use of antiplatelet medication\n* Moderate to severe renal insufficiency (creatinine clearance \\\u003C30 ml\u002Fmin or on dialysis)\n* Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (for Swedish patients)",{"count":347,"type":21},332,[24],"The goal of this randomized clinical trial is to assess the benefit of early resumption versus late resumption of oral anticoagulation medication in adults with atrial fibrillation undergoing surgery for chronic subdural hematoma. The main questions it aims to answer are:\n\n* Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery result in fewer thromboembolic complications, without increasing the risk for bleeding?\n* Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery affect the risk of reoperation, functional outcome, mortality, and healthcare use?\n\nResearchers will compare early anticoagulation resumption (5 days) and late anticoagulation resumption (30 days) after chronic subdural hematoma surgery.\n\nParticipants will either resume the medication 5 days or 30 days after the surgery. The participants will be followed up for 3 months after the surgery.",[27,351],"Atrial Fibrillation (AF)",[353,354,355,356,357,358,359,360,361],"chronic subdural hematoma","atrial fibrillation","oral anticoagulation","warfarin","direct oral anticoagulants","surgery","stroke","hemorrhage","prognosis","2025-08-21",{"date":364,"type":37},"2025-08-22",{"date":366,"type":37},"2025-07-07",{"date":368,"type":21},"2027-06",{"name":370,"class":44},"Rahul Raj",6,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":77},"100555322","phase-1-chronic-subdural-hematoma-treatment-with-intra-arterial-bevacizumab-injection-100555322","NCT06510582","Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection","Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1\u002F2 Clinical Trial","CHAI","Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* Radiographic evidence of chronic subdural hematoma, including\n\n  1. Persistence of subdural blood more than 10 days after index traumatic injury or event\n  2. Presence of mixed density blood\n  3. Presence of subdural membranes\n* Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study.\n* Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy).\n* Patients with known hypersensitivity to bevacizumab.\n* Patients with radiographic evidence of mass effect.\n* Patients have focal neurological deficits attributed to subdural hematoma.\n* Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.\n* Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.\n* Emergent surgical evacuation is required for the patient.\n* Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.\n* Coagulation abnormalities, including platelet count \\\u003C100,000 and\u002For international normalized ratio of \\\u003C1.5 despite attempts for correction.\n* Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.\n* Patient has known active systemic infection or sepsis.\n* Patient has contradiction to anesthetic agents used for conscious sedation\u002Fmonitored anesthesia care (MAC).\n* Patient has life expectancy of less than six months due to comorbid terminal conditions.\n* Patient has a premorbid modified Rankin score (mRS) of 5 or greater.\n* Concurrent participation in another research protocol for investigation of an experimental therapy.",{"count":381,"type":21},140,[383,244],"PHASE1","The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH).\n\nThe main questions it aims to answer are:\n\n* Is bevacizumab infusion safe in cSDH patients?\n* Is bevacizumab infusion effective in treating cSDH?",[27],[64,387,388,389,198],"Chronic intracranial subdural hematoma","Vascular endothelial growth factor","Bevacizumab","2025-06-25",{"date":392,"type":37},"2025-07-01",{"date":394,"type":37},"2024-06-17",{"date":396,"type":21},"2028-06",{"name":398,"class":44},"The Cooper Health System",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":418,"locationsCount":77},"100575473","middle-meningeal-artery-embolization-for-patients-with-chronic-subdural-hematoma-100575473","NCT06772740","Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma","Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)","Inclusion Criteria:\n\n1. Age \\>=18\n2. pre-mRS 0-3\n3. Hematoma thickness \\>=10mm\n4. Having at least one risk factor Risk factor: Age \\>=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score \\>3, Preoperative volume \\>=130ml, Preoperative midline shift \\>=8mm, CT appearance (Homogeneous, laminar or separated)\n\nExclusion Criteria:\n\n1. Cr \\>=1.8\n2. Plt \\\u003C50,000, PT-INR \\>2\n3. Life expectancy \\\u003C6 months",{"count":407,"type":21},600,[24],"COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.",[411,27],"Endovascular Treatment","2025-05-26",{"date":414,"type":37},"2025-05-28",{"date":152,"type":37},{"date":417,"type":21},"2029-03-31",{"name":419,"class":44},"Kazutaka Uchida",{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":17,"minAge":426,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":327,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":4},"100571322","phase-2-tranexamic-acid-therapy-for-the-treatment-of-subdural-hematomas-100571322","NCT06718751","Tranexamic Acid Therapy For The Treatment of Subdural Hematomas","Inclusion Criteria:\n\n* CT scan demonstrating existence of a subdural hematoma, unilateral or bilateral, containing a chronic component\n* Neurosurgeon evaluation deemed patient to not need surgery\n* Diagnosis within the last 14 days\n* Signed informed consent\n* Competence to take study medications properly and regularly or access to care giver that is able to comply with accurate study medication administration\n\nExclusion Criteria:\n\n* Planned surgery, burr-hole craniostomy or mini-craniotomy for their chronic subdural hematoma based on one or more of the following symptoms: medically intractable headache, midline shift \\>5mm, SDH thickness \\>10mm, increased ICP, imminent death within 24 hours\n* Structural causes for subdural hemorrhage (arachnoid cysts, cortical vascular malformations)\n* Recent ischemic stroke\n* Other concomitant intracranial pathology (intracranial malignancy)\n* Active malignancy\n* Need for chronic therapeutic anticoagulation (i.e. atrial fibrillation)\n* Acute subdural hematoma with no chronic component\n* Active treatment for deep vein thrombosis, pulmonary embolism or cerebral thrombosis (secondary prophylaxis is not considered to be active treatment)\n* Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency\n* History of thrombosis or thromboembolism, including retinal vein or artery occlusions\n* An intrinsic risk of thrombosis or thromboembolism\n* Aneurysmal subarachnoid hemorrhage\n* Concurrent use of Factor IX complex concentrate or anti-inhibitor coagulant concentrates\n* Concurrent use of all-trans retinoic acid\n* Active intravascular clotting or disseminated intravascular coagulation\n* Need for tissue plasminogen activators\n* Known hypersenstivity to TXA or any of the ingredients\n* Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) \\\u003C 60 mL\u002Fmin or creatinine \\> 2.8 mg\u002FdL\n* Hematuria, caused by diseases of renal parenchyma\n* Pregnancy or breastfeeding\\*\n* Concomitant hormonal contraception\\*\n* History of convulsions\n* History of angioplasty with cardiac stent placement or mechanical heart valve\n* Any concern from the attending physician","21 Years","95 Years",{"count":429,"type":21},240,[244],"This Phase II randomized, placebo-controlled, double-blinded trial is the first step in our endeavor to improve the clinical outcomes of patients with chronic subdural hematomas (cSDH). Patients who are deemed to not need surgery for their cSDH will be randomly assigned to either the treatment group or the placebo group. Both groups will take a 650mg tablet once daily for 21 weeks and follow the standard of care monitoring for cSDH which is neurological testing and imaging at 6 weeks, 12 weeks, and 21 weeks. With this study, we hope to establish the safety and efficacy of using TXA PO to resolve cSDH without the need for surgical intervention.",[27],[434],"tranexamic acid","2025-05-12",{"date":437,"type":37},"2025-05-14",{"date":439,"type":21},"2025-10",{"date":441,"type":21},"2030-10",{"name":443,"class":44},"Baylor College of Medicine",{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":17,"minAge":426,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":327,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":4},"100551949","puerto-rico-embolization-of-the-middle-meningeal-artery-for-the-treatment-of-chronic-subdural-hematoma-trial-premma-100551949","NCT06466733","Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)","PREMMA","Inclusion Criteria:\n\n* Age ≥ 21\n* Speak and understand Spanish or English\n* Resident of Puerto Rico\n* Glasgow coma scale ≥ 14\u002F15\n* Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)\n* Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)\n* No previous surgical or endovascular treatment for symptomatic cSDH\n* Signed informed consent for participation in the study by the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Acute subdural hematoma\n* Focal, non-hemispheric localization of cSDH\n* Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging\n* Imaging evidence of skull fracture over the subdural hematoma\n* Presence of any cerebrospinal fluid (CSF) shunt\n* Imaging evidence of midline shift ≥ 10 mm\n* Imaging evidence of basal cistern effacement\n* Imaging evidence of dilatation of lateral ventricles\n* Imaging evidence of uncal herniation\n* Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH\n* Contraindications for angiography (i.e., complex anatomy or kidney failure)\n* Comorbidity making follow-up impossible\n* Pregnancy\n* Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure\n* Absence of medical insurance",{"count":452,"type":21},658,[24],"Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.",[27],[64,457,458,459,460,461,462],"Embolization of the middle meningeal artery","Surgical evacuation","Hemorrhage","Intracranial hemorrhage","Cerebrovascular disease","Chronic disease","2025-05-02",{"date":465,"type":37},"2025-05-07",{"date":467,"type":21},"2025-05",{"date":469,"type":21},"2032-07",{"name":471,"class":44},"Juan M. Ramos Acevedo",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":494,"locationsCount":496},"100586158","effect-of-the-postoperative-trendelenburg-position-on-chronic-subdural-hematoma-recurrence-100586158","NCT06911736","Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence","Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial","POTHeR","Inclusion Criteria:\n\n* The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,\n* History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting\n* Simultaneous participation in any other clinical trial.",{"count":481,"type":21},254,[24],"Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.\n\nMaterials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).",[27,485,59,273,486,487],"Trendelenburg","Prognosis","Clinical Trials","2025-04-16",{"date":490,"type":37},"2025-04-22",{"date":492,"type":37},"2024-06-01",{"date":74,"type":21},{"name":495,"class":44},"Universidad de Antioquia",3,{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":504,"targetDuration":506,"studyType":141,"phases":4,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":521,"locationsCount":314},"100574449","registry-of-chronic-subdural-hematoma-100574449","NCT06759428","Registry of Chronic Subdural Hematoma","CSDH Registry","Inclusion Criteria:\n\n* Patients diagnosed with CSDH\n* 18 years or older\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the registry",{"count":505,"type":21},1500,"3 Months","The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:\n\n1. What are the characteristics of patients with CSDH when they are diagnosed?\n2. What treatments do patients with CSDH receive?\n3. What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?\n\nParticipants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.",[27,509],"Registry",[64,511,509,512,513,514],"Traumatic Brain Injury","Treatment outcome","Burr hole drainage","modified Rankin Scale","2025-01-06",{"date":517,"type":37},"2025-01-07",{"date":519,"type":37},"2021-10-01",{"date":127,"type":21},{"name":522,"class":44},"Erasmus Medical Center",{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":327,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":496},"100548975","efficacy-and-safety-of-chinese-herbal-huoxue-lishui-formula-for-chronic-subdural-hematoma-100548975","NCT06427980","Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma","Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail","CHARM","Inclusion Criteria:\n\n1. Age between 18 and 90 years and either gender will be included.\n2. Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).\n3. Primary hematoma or residual hematoma after burr-hole drainage.\n4. Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤ 2.\n5. No risk of brain herniation or recent immediate need for surgery will be evaluated by 2 attending neurosurgeons.\n6. Written informed consent will be obtained from patients or their next of kins according to their cognitive status.\n\nExclusion Criteria:\n\n1. Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.\n2. Progressive or apparent neurological deficit with a GCS score \\\u003C 14 or mRS score \\> 2.\n3. Midline shift \\> 10 mm on the radiological image.\n4. Previous medication treatment for CSDH.\n5. Previous intracranial surgery for any other neurological disorder.\n6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.\n7. Known hypersensitivity or allergy to HXLS or to any of the ingredients.\n8. Malignant tumors.\n9. Life expectancy of \\\u003C 1 year.\n10. Abnormal liver function or liver diseases, including uncontrolled hepatitis (alanine transaminase \\> 120 U\u002FL).\n11. Severe renal impairment (estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin or serum creatinine \\> 150 μmol\u002FL).\n12. Moderate or severe anemia (hemoglobin ≤ 90 g\u002FL).\n13. Severe coagulopathy or a high risk of life-threatening bleeding.\n14. Poor medication conditions or the presence of severe comorbidities such that treatment cannot be tolerated or follow-up cannot be completed.\n15. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, angiotensin-converting enzyme inhibitors, or other traditional Chinese medicines before randomization or are expected to take such medications in the next 24 weeks.\n16. Difficulty swallowing oral medication.\n17. Pregnancy or lactation.\n18. Participating in another study.",{"count":532,"type":21},160,[24],"A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.",[27],[27,537,538,539,540],"Chinese herbal formula","HuoXue LiShui","Pharmacotherapy","Randomized controlled trial","2024-12-26",{"date":543,"type":37},"2024-12-30",{"date":545,"type":21},"2025-02-01",{"date":547,"type":21},"2026-03-28",{"name":183,"class":44},{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":568,"leadSponsor":570,"locationsCount":77},"100540944","spinal-csf-leaks-in-chronic-subdural-hematoma-100540944","NCT06323434","Spinal CSF Leaks in Chronic Subdural Hematoma","SPICE","Inclusion Criteria:\n\n1. Chronic subdural hematoma on imaging (CT\u002FMRI)\n2. Age: 18 years or older\n3. Informed consent\n\nExclusion Criteria:\n\n1. General contraindications for MRI examination (e.g., pacemaker wearers, implanted insulin, or pain pump, neurostimulator, etc.)\n2. Recurrent chronic subdural hematoma and previously performed diagnostics and treatment in compliance to the current cSDH SOP\n3. Severe brain injury, acute subdural hematoma, epidural hematoma, subarachnoid hemorrhage",{"count":557,"type":21},220,"Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8\u002F100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population.\n\nThe spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks.\n\nCurrently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH.\n\nObjective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures.",[27],[561,562,563],"Spinal CSF leak","Spontaneous Intracranial Hypotension","CSF-venous fistula","2024-06-24",{"date":566,"type":37},"2024-06-26",{"date":564,"type":37},{"date":569,"type":21},"2026-12",{"name":571,"class":44},"University of Freiburg",{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":286},"100459789","swedish-trial-on-embolization-of-middle-meningeal-artery-versus-surgical-evacuation-in-chronic-subdural-hematoma-100459789","NCT05267184","Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma","SWEMMA","Inclusion Criteria:\n\n1. Men and women 18-89 y\u002Fo\n2. Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH\n3. Clinical and\u002For radiological status indicating neurosurgical treatment\n4. Markwalder Scale score \\\u003C2\n5. Glasgow coma Scale score \\>13\n6. Able to provide signed informed consent\n\nExclusion Criteria:\n\n1. Acute subdural hematoma\n2. Focal, non-hemispheric cSDH\n3. Midline shift \\>10 mm and\u002For effaced basal cisterns and\u002For significant dilatation of one or both lateral ventricle temporal horns and\u002For incipient uncal herniation\n4. Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)\n5. Contraindications to angiography\n6. Dependency defined as mRS \\>3\n7. Life expectancy \\\u003C6 months\n8. Comorbidity deemed making follow up impossible\n9. Participation in other interventional clinical study\n10. Pregnancy","89 Years",{"count":581,"type":21},288,[24],"The SWEMMA trial is an open, national, multi-center, prospective, randomized (1:1), superiority trial designed to assess impact on reoperation rates for chronic subdural hematoma with a head-to-head comparison of embolization of the middle meningeal artery (intervention) with standard neurosurgical hematoma evacuation (control).",[27],"2024-04-08",{"date":587,"type":37},"2024-04-09",{"date":589,"type":37},"2022-03-28",{"date":591,"type":21},"2027-03",{"name":593,"class":44},"Region Skane"]