[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507612":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":43,"locations":53,"responsibleParty":149,"collaborators":152,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":164,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":22,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":56,"whyStopped":22,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Brain Trauma Foundation","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"1st stage - prophylactic","EXPERIMENTAL","External lumbar drainage @15mmHg if intracranial pressure is not raised on admission",[13],"Procedure: External Lumbar drainage",{"label":15,"type":10,"description":16,"interventionNames":17},"2nd stage - treatment","External lumbar drainage @20mmHg if \u002F when intracranial pressure \\>20mmHg and tier 1 therapies cannot achieve ICP\\\u003C20mmHg",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Usual treatment","NO_INTERVENTION","Usual treatment as per SIBICC algorithm",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"PROCEDURE","External Lumbar drainage","ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml\u002Fhour drainage",[9,15],[30,34,36,39],{"name":31,"affiliation":32,"role":33},"Halinder S Mangat, MD MSc","Brain Trauma Foundation; Kansas University Medical Center Research Institute","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Jamshid Ghajar, MD PhD",{"name":37,"affiliation":38,"role":33},"Gregory Hawryluk, MD PhD","Cleveland Clinic Foundation, Brain Trauma Foundation",{"name":40,"affiliation":41,"role":42},"Bradley Dengler, MD","Military Traumatic Brain Injury Initiative, Uniformed Services University","STUDY_CHAIR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":22,"email":48},"Carlos Morales, MPH","CONTACT","240-6536638","carlos.morales.ctr@usuhs.edu",{"name":50,"role":46,"phone":51,"phoneExt":22,"email":52},"Halinder S Mangat, MD, MSc","913-5886970","elastic@braintrauma.org",[54,75,88,105,121,133],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of Florida","RECRUITING","Gainesville","Florida","32610","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-82.32483,29.65163,{"lat":66,"lon":65},[69,72],{"name":70,"role":46,"phone":22,"phoneExt":22,"email":71},"Ivan DaSilva, MD","Ivan.RochaFerreiraDaSilva@neurology.ufl.edu",{"name":73,"role":46,"phone":22,"phoneExt":22,"email":74},"Magali Jorand-Fletcher","magali.jorand-fletcher@neurology.ufl.edu",{"facility":76,"status":56,"city":77,"state":78,"zip":79,"country":60,"countryCode":61,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Kansas University Medical Center","Kansas City","Kansas","66160",{"type":63,"coordinates":81},[82,83],-94.62746,39.11417,{"lat":83,"lon":82},[86],{"name":50,"role":46,"phone":22,"phoneExt":22,"email":87},"hmangat@braintrauma.org",{"facility":89,"status":56,"city":90,"state":91,"zip":92,"country":60,"countryCode":61,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":63,"coordinates":94},[95,96],-96.80667,32.78306,{"lat":96,"lon":95},[99,102],{"name":100,"role":46,"phone":22,"phoneExt":22,"email":101},"Alex Valadka, MD","alex.valadka@utsouthwestern.edu",{"name":103,"role":46,"phone":22,"phoneExt":22,"email":104},"Aisha Qureshi","Aisha.Qureshi@utsouthwestern.edu",{"facility":106,"status":56,"city":107,"state":91,"zip":108,"country":60,"countryCode":61,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Brooke Army Medical Center","Fort Sam Houston","78234",{"type":63,"coordinates":110},[111,112],-98.4417,29.45303,{"lat":112,"lon":111},[115,118],{"name":116,"role":46,"phone":22,"phoneExt":22,"email":117},"Geoffrey Peitz, MD","geoffrey.w.peitz.mil@health.mil",{"name":119,"role":46,"phone":22,"phoneExt":22,"email":120},"Ryan Morton, MD","ryan.p.morton.mil@health.mil",{"facility":122,"status":56,"city":123,"state":91,"zip":124,"country":60,"countryCode":61,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of Houston Medical Center","Houston","77030",{"type":63,"coordinates":126},[127,128],-95.36327,29.76328,{"lat":128,"lon":127},[131],{"name":132,"role":46,"phone":22,"phoneExt":22,"email":22},"Ryan Kitagawa, MD, PhD",{"facility":134,"status":56,"city":135,"state":91,"zip":136,"country":60,"countryCode":61,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"University of Texas","San Antonio","78249",{"type":63,"coordinates":138},[139,140],-98.49363,29.42412,{"lat":140,"lon":139},[143,146],{"name":144,"role":46,"phone":22,"phoneExt":22,"email":145},"Michael McGinity, MD","mcginity@uthscsa.edu",{"name":147,"role":46,"phone":22,"phoneExt":22,"email":148},"Megan Jackson","jacksonm1@uthscsa.edu",{"type":33,"investigatorFullName":150,"investigatorTitle":151,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Halinder Mangat","Director of Research",[153,156,158,160],{"name":154,"class":155},"Uniformed Services University of the Health Sciences","FED",{"name":157,"class":6},"University of Kansas",{"name":159,"class":6},"The Cleveland Clinic",{"name":161,"class":6},"Weill Medical College of Cornell University","100507612","external-lumbar-drainage-to-reduce-icp-in-severe-tbi-a-phase-1-clinical-trial-100507612",false,"NCT05889650","External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial","External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial","ELASTIC","Inclusion Criteria:\n\n1. 18-65 years age\n2. Glasgow Coma Scale (GCS) 3-8\n3. Pupils symmetric and bilaterally reactive\n4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT\n5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT\n6. First randomization and intervention may be commenced within 24 hours of injury\n7. ELD safety score ≥5\n\nExclusion Criteria:\n\n1. GCS \\>8\n2. Cisterns on CT completely effaced\n3. Midline shift on CT \\>5mm\n4. GCS 3 with dilated and fixed pupils\n5. Uncal or tonsillar herniation on admission or post-operative brain CT\n6. Temporal lobe contusions with effaced ipsilateral cisterns\n7. Penetrating TBI\n8. Primary hemicraniectomy\n9. Pregnancy\n10. Prisoners\n11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care\n12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year\n13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \\\u003C50,000, or severe spinal deformity.\n14. posterior fossa hemorrhage","ALL","18 Years","65 Years",{"count":174,"type":175},30,"ESTIMATED","INTERVENTIONAL",[178],"NA","The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \\\u003C5mm without increasing the risk of neurological worsening or cerebral herniation.\n\nAll participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.",[181,182],"Severe Traumatic Brain Injury","Intracranial Hypertension",[184,185,186,187],"Traumatic brain injury","intracranial pressure","intracranial hypertension","lumbar drainage","2026-04-20",{"date":190,"type":191},"2026-04-22","ACTUAL",{"date":193,"type":191},"2024-06-24",{"date":195,"type":175},"2028-06-30",{"name":5,"class":6},6]