[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Meditech Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100620491","tbi--efficacy-of-steroids-in-acute-vasogenic-edema-100620491",false,"NCT07358312","TBI- Efficacy of Steroids in Acute Vasogenic Edema","Traumatic Brain Injury - Efficacy of Steroids in Acute Vasogenic Edema","TBI-SAVE","Inclusion Criteria:\n\n* Age between 18 and 70 years.\n* Mild or moderate TBI, treated in the emergency department within the first 24-72 hours post-trauma.\n* Abnormal CT scan with cerebral contusion, with or without midline shift \\>3 mm, and\u002For compression of basal cisterns.\n* At least 2 systems with abnormal findings on non-invasive monitoring (ONSD ≥6 mm, reduced MCV, PI \\>1.3 or MCA FV \\\u003C20cm\u002Fsec on transcranial Doppler, or ICP waveform with P2\\>P1).\n* Patients with or without polytrauma, with an expected survival of\\>24 h.\n* TBI with brain contusion with medical or surgical procedures indicated within the first 24 h (ventriculostomy, cisternostomy, decompressive craniectomy, or cranial decompression).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>70 years.\n* Severe TBI (GCS = 3), suspected brain death, or head AIS = 6 (non-survivable injury).\n* Normal CT scan on initial assessment.\n* Clinical signs of cerebral herniation upon admission.\n* Severe polytrauma or massive brain injury with an expected survival \\\u003C24 h.\n* Pre-existing neurological disorders that interfere with outcome assessment, preexisting conditions contraindicating steroid therapy or pre-existing conditions with permanent steroid therapy.","ALL","18 Years","70 Years",{"count":21,"type":22},280,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the impact of dexamethasone treatment in traumatic brain injury patients with vasogenic edema in the second week after the trauma, administered in centers where this intervention has been considered to treat brain edema. The main question it aims to answer is: Does dexamethasone in a regimen of 8mg\u002F8h for 5 days improve vasogenic edema in patients after 5 days of their trauma? Participants already receiving this treatment as part of their regular medical care in emergency settings, general wards, or ICU settings for TBI will be included, and data will be compared with patients with the same criteria but who do not receive the treatment.",[26],"Traumatic Brain Injury",[28,26,29,30],"Vasogenic Edema","Steroids","Brain Trauma","NOT_YET_RECRUITING","2026-01-13",{"date":34,"type":35},"2026-01-22","ACTUAL",{"date":37,"type":22},"2026-03-01",{"date":39,"type":22},"2029-12-01",{"name":41,"class":42},"Meditech Foundation","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":53,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100575771","effectiveness-of-surgical-procedures-for-acute-cranial-expansion-in-traumatic-brain-injury-100575771","NCT06776614","Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury","A Comparative-effectiveness Study on Expansion Craniotomy Versus Decompressive Craniectomy for Surgical Management of Traumatic Brain Injury in Patients With Intracranial Compartment Syndrome","E-SPACE-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal computed tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm at the same side of the CT´s primary injury or and\u002For an abnormal pupillometry with a reduced (Maximum Contraction Velocity) MCV in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans- Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Middle Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Pulse Wave (ICPPW) ICPPW2 \\> ICPPW1 waveform pattern in the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Cranial decompression or cranial expansion surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Cranial decompression or cranial expansion surgical procedures performed \\> 24 hours after the trauma.",{"count":52,"type":22},292,"24 Months","Traumatic brain injury (TBI) patients often exhibit an increase in their intracranial volume due to blood collection or brain tissue edema. When the volume of any intracranial compartment exceeds a critical threshold, the compensatory mechanisms become exhausted, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS). The presence of this condition exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove to be insufficient, cranial decompression is recommended, with decompressive craniectomy (DC) being the preferred technique.\n\nAlthough its effectiveness has been demonstrated, DC is also associated with an incidence of complications. Expansive craniotomy (EC) has been proposed as an alternative that can increase the benefits of cranial decompression provided by DC while reducing the associated complications. This observational study will compare the functional outcomes and complications of patients managed by DC and EC.",[56,57],"Traumatic Brain Injuries","Intracranial Hypertension",[26,59,60,61],"Intracranial Compartment Syndrome","Decompressive Craniectomy","Expansive Craniotomy","2025-05-05",{"date":64,"type":35},"2025-05-08",{"date":66,"type":22},"2025-07-08",{"date":68,"type":22},"2027-12-31",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":53,"studyType":23,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":88,"locationsCount":4},"100575428","security-and-effectiveness-assessment-of-locking-systems-in-ventriculostomy-for-traumatic-brain-injury-100575428","NCT06772155","Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury","A Comparative Effectiveness Study on Catheter Locking Device Versus Standard Ventriculostomy for Surgical Management of Traumatic Brain Injury Patients With Intracranial Compartment Syndrome","SEALS-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal Computed Tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3 mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm on the same side of the CT´s primary injury and\u002For an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Medium Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Wave Form (ICPWF)2 \\> ICPWF1 waveform pattern on the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Ventriculostomy surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler, and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Ventriculostomy surgical procedures performed \\> 24 hours after the trauma.",{"count":52,"type":22},"This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and\u002For reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.",[56,57],[82,26,83],"External Ventricular Drain","Cranial Compartment Syndrome",{"date":64,"type":35},{"date":86,"type":22},"2025-07-05",{"date":68,"type":22},{"name":41,"class":42},""]