[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spontaneous-intracerebral-hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spontaneous-intracerebral-hemorrhage":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,78,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100618851","phase-3-efficacy-of-prophylactic-levetiracetam-for-improving-functional-outcome-in-the-acute-phase-of-intracerebral-haemorrhage-a-randomised-double-blind-placebo-controlled-phase-3-trial-100618851",false,"NCT07336992","Efficacy of Prophylactic Levetiracetam for Improving Functional Outcome in the Acute Phase of Intracerebral Haemorrhage: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial","PEACH2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI\n* Onset of neurologic symptoms within 24 hours\n* NIHSS score on admission ≤ 25\n* Informed consent given by the patient or his\u002Fher legal representative\n* Patients benefiting from a social insurance system or a similar system\n\nExclusion Criteria:\n\n* Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or tumour\n* Current use of antiseizure drugs or history of epilepsy\n* Severe renal insufficiency (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Pregnancy or breastfeeding\n* Previous history of severe depression or psychotic disorder\n* Known terminal illness\n* Known allergy or hypersensitivity to levetiracetam\n* Known allergy or hypersensitivity to microcrystalline cellulose or lactose\n* Being under legal protection","ALL","18 Years",{"count":19,"type":20},580,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Epileptic seizures are a common complication at the acute phase of intracerebral haemorrhage (ICH). The incidence of seizures occurring within 7 days reaches 40% when subclinical seizures are diagnosed by continuous electroencephalogram (EEG).\n\nSome studies have suggested that early seizures are associated with haematoma expansion (Vespa., Neurology 2003), worse neurological outcomes (Gilmore., Stroke 2016) or increased mortality. By contrast, other studies have shown no association of acute seizures with long-term mortality and outcome. However, the interpretation of these works is subject to bias because almost all studies were based on clinical detection of seizures only, while it has been shown that most early seizures after ICH are clinically unrecognised and can only be diagnosed with EEG monitoring.\n\nThe PEACH trial, a double-blind, randomised, placebo-controlled, showed that clinical and\u002For electrographic seizures occur in more than 40% of patients with ICH and that Levetiracetam (LVT) is safe and effective in preventing these seizures. However, it remains unclear whether preventing acute seizures might lead to improved functional outcomes after ICH. An adequately powered randomised controlled trial is needed to answer whether primary seizure prophylaxis improves functional outcome in this setting. Answering this question would result in an important change in ICH acute care guidelines, which currently do not recommend primary prophylactic antiseizure treatment. As compared to research in acute ischemic stroke management, fewer clinical trials have been conducted in acute ICH and no effective medical treatments are available in this subset of patients.\n\nThe main objective of PEACH 2 is to establish if prophylactic antiseizure therapy with LVT improves functional outcome in adults with acute spontaneous ICH. Functional outcome assessed by the modified Rankin score (mRS score) six months after acute ICH will be compared between patients receiving prophylactic antiseizure therapy with levetiracetam and patients receiving placebo.\n\nThe secondary objectives are to examine the effect of prophylactic antiseizure therapy with levetiracetam versus placebo on:\n\n* the number of early and late clinical seizures, on the short term and long term evolution of the neurologic deficit as assessed by the NIHSS, on long term functional outcome (12 months) as assessed by the mRS, on quality of life and cognitive impairment, and on haematoma expansion and mass effect on control brain imaging\n* the frequency of side effects at 1 and 6 months, pneumonia at 1 month, delirium at 1 month, anxiety and depression at 1 and 6 months, and all-cause mortality at 1, 6 and 12 months.\n\n  580 patients will be recruited over 3 years.",[26],"Spontaneous Intracerebral Hemorrhage",[28],"supratentorial","NOT_YET_RECRUITING","2026-01-02",{"date":32,"type":33},"2026-01-13","ACTUAL",{"date":30,"type":20},{"date":36,"type":20},"2030-01-02",{"name":38,"class":39},"Hospices Civils de Lyon","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100574728","phase-3-the-fifth-intensive-preventing-secondary-injury-in-acute-cerebral-haemorrhage-trial-within-act-global-100574728","NCT06763055","The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL","INTERACT5","Inclusion Criteria:\n\n1. Age between 18 and 80 years old\n2. Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging\n3. Presentation to hospital within 24 hours of symptom onset (or last seen well)\n4. Hematoma volume ≥10 mL or any volume post-surgery\n5. NIHSS score \\>8\n6. GCS ≥8\n7. Provide written informed consent by patient (or approved surrogate)\n\nExclusion Criteria:\n\n1. Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke\n2. Isolate intraventricular haemorrhage\n3. Chronic Kidney Disease\n4. Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up\n5. Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability)\n6. Women who are pregnant or lactating\n\n   Exclusion Criteria related to use of deferoxamine:\n7. Previous chelation therapy or known hypersensitivity to deferoxamine products;\n8. Severe iron deficiency anaemia (haemoglobin \\\u003C7 g\u002FdL or requiring regular blood transfusions);\n9. Taking iron supplements containing \\>325 mg of ferrous iron;\n10. Serum creatinine \\>2 mg\u002FdL;\n11. Patients with known heart failure taking \\>500 mg of vitamin C\n\n    Exclusion criteria related to the use of colchicine:\n12. Allergic to colchicine\n13. Myelodysplastic hypoplasia, or liver or severe renal failure\n14. Use of medication which may interact with colchicine (e.g., strong CYPsA4 inhibitors such as ketoconazole, strong P-glycoprotein inhibitors such as fluconazole)","80 Years",{"count":50,"type":20},2000,[23],"This is a domain within the ACT-GLOBAL platform trial to compare the effectiveness of early and appropriate pharmacological interventions in acute intracerebral hemorrhage (ICH) to control secondary brain injury. Up to 2000 patients with presumed spontaneous supratentorial intracerebral hemorrhage (ICH) will be followed for 6 months (or death, if prior to 6 months).\n\nAdaptive interim analyses will be used, with statistical triggers to determine if any of the interventions are superior to control. The end of the trial is defined as the date that all participants have completed their 6-month assessment.\n\nA large amount of preclinical data indicates that the outcome from ICH is linked to the detrimental effects of breakdown substances from brain bleeds. However, there remains a lack of compelling evidence supporting the effectiveness of any pharmacological intervention that can mitigate the secondary cerebral injury. The INTERACT domain aims to assess the effectiveness of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, to standard of care alone, on improving functional outcome in patients with spontaneous supratentorial ICH.\n\nThose patients who meet eligibility criteria will be randomized to receive one of four interventions:\n\n1. No deferoxamine mesylate and no colchicine (labeled as control)\n2. Deferoxamine mesylate only: deferoxamine mesylate at a dose of 32mg\u002Fkg\u002Fday via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days.\n3. Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days.\n4. Both deferoxamine mesylate and colchicine: deferoxamine mesylate at a dose of 32mg\u002Fkg\u002Fday via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days.",[54,26,55,56,57],"Intracerebral Hemorrhage","Supratentorial Intracerebral Haemorrhage","Acute Intracerebral Haemorrhage","Acute Stroke",[59,57,60,54,61,62,63,64,65,66],"Stroke","ICH","Platform Trial","Adaptive Platform Trial","Supratentorial ICH","secondary brain injury","deferoxamine mesylate","colchicine","RECRUITING","2025-04-08",{"date":70,"type":33},"2025-04-10",{"date":72,"type":33},"2025-02-27",{"date":74,"type":20},"2028-01",{"name":76,"class":39},"The George Institute",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100584686","rehabilitation-paired-with-vns-for-motor-function-recovery-100584686","NCT06892574","Rehabilitation Paired with VNS for Motor Function Recovery","A Trial of Rehabilitation Paired with VNS for Motor Function Recovery in Post-ICH Patients (Recovery Study)","Inclusion Criteria:\n\n* Age ≥22 years and \\\u003C80 years, all gender is acceptable.\n* History of unilateral supratentorial intracerebral hemorrhage ≥ 6 months but \\\u003C 5 years.\n* Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.\n* Right- or left-sided weakness of upper extremity.\n* Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.\n* Subjects have good compliance and can complete the visits after surgery.\n\nExclusion Criteria:\n\n* History of ischemic stroke.\n* Cerebral hemorrhage resulting from tumors, trauma, aneurysms, or hemorrhagic transformation of ischemic stroke.\n* Presence of ongoing dysphagia or aspiration difficulties.\n* Prior injury to vagus nerve, either bilateral or unilateral.\n* Subject receiving medication that may significantly interfere with actions of VNS on neurotransmitter systems at study entry, clinic rehabilitation follow-up timepoint, or home rehabilitation follow-up timepoint, such as centrally acting cholinoceptor blockers, centrally acting adrenoceptor blockers, norepinephrine re-uptake inhibitors, etc.\n* Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).\n* Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).\n* Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \\\u003C 6).\n* Current requirement, or likely future requirement, of diathermy.\n* Current use of any other stimulation device, such as a pacemaker or other neurostimulator.\n* Pregnancy or plans to become pregnant or to breastfeed during the study period.\n* Participated in any other clinical trials within the preceding 3 months.\n* Not considered to be applicable by the investigator.","22 Years","79 Years",{"count":88,"type":20},10,[90],"NA","The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous intracerebral hemorrhage (ICH).\n\nResearchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA).\n\nParticipants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.",[26,93,94,95,96],"Motor Function","Upper Extremity Injury","Rehabilitation","Vagus Nerve Stimulation",[59,98,99,96,100,101,95],"Hemorrhagic Stroke","Upper Extremity Paresis","Neuromodulation","Randomized Controlled Trial","2025-03-23",{"date":104,"type":33},"2025-03-26",{"date":106,"type":20},"2025-04-01",{"date":108,"type":20},"2027-12-30",{"name":110,"class":39},"First Affiliated Hospital of Fujian Medical University",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":40},"100562357","noncontrast-ct-based-deep-learning-for-predicting-hematoma-expansion-risk-in-patients-with-spontaneous-intracerebral-hemorrhage-100562357","NCT06602115","Noncontrast CT-Based Deep Learning for Predicting Hematoma Expansion Risk in Patients with Spontaneous Intracerebral Hemorrhage","NCCT-DL-HE","Inclusion Criteria:\n\n1. Primary, spontaneous (non-traumatic) intracerebral hemorrhage (ICH).\n2. Age ≥ 18 years.\n3. Baseline CT performed within 24 hours of ICH symptom onset or last seen well (LSW).\n4. Follow-up CT within 72 hours.\n\nExclusion Criteria:\n\n1. Secondary ICH caused by trauma, vascular anomalies (e.g., aneurysm, cavernous angioma, arteriovenous malformation), brain tumor, or hemorrhagic transformation in brain infarction.\n2. Primary intraventricular hemorrhage (IVH).\n3. Surgical treatment with external ventricular drain placement or craniotomy.\n4. Obvious artifacts observed in CT images.",{"count":50,"type":20},"OBSERVATIONAL","Hematoma expansion is an independent predictor of poor prognosis and early neurological deterioration in patients with spontaneous intracerebral hemorrhage. Early identification of high-risk patients and timely targeted medical interventions may provide a crucial opportunity to limit hematoma growth and improve neurological outcomes. This study aims to develop an end-to-end deep learning model based on noncontrast computed tomography images to predict the risk of hematoma expansion in patients with spontaneous intracerebral hemorrhage. This model could serve as a valuable risk stratification tool for patients with hematoma expansion, facilitating targeted treatment and providing clinicians with streamlined decision-making support in emergency situations.",[26,122],"Hematoma Expansion",[26,122,124],"Deep Learning","2024-09-17",{"date":127,"type":33},"2024-09-19",{"date":129,"type":20},"2024-09-25",{"date":131,"type":20},"2024-12",{"name":133,"class":39},"Qiang Yu"]