Sponsor:
Brain Trauma Foundation
Code:
NCT05889650
Conditions
Severe Traumatic Brain Injury
Intracranial Hypertension
Eligibility Criteria
Sex: All
Age: 18 - 65
Healthy Volunteers: Not accepted
Interventions
External Lumbar drainage
Brief summary:
Conditions
Severe Traumatic Brain Injury
Intracranial Hypertension
Study ID
NCT05889650
Start date
Jun 24, 2024
Status verified date
Apr, 2026
Completion date
Jun 30, 2028
Anticipated
Primary completion date
Jun 15, 2028
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 65
Healthy Volunteers: Not accepted
Enrollment
30 participants
Anticipated
Allocation
Randomized
Intervention Model
Sequential
Primary purpose
Treatment
Arms
experimental: 1st stage - prophylactic
experimental: 2nd stage - treatment
no intervention: Usual treatment
Interventions
External Lumbar drainage
Primary outcome measure
Central contacts
Locations
University of Florida
Recruiting
Gainesville, Florida, United States, 32610
Contacts
Ivan DaSilva, MD
Ivan.RochaFerreiraDaSilva@neurology.ufl.eduMagali Jorand-Fletcher
magali.jorand-fletcher@neurology.ufl.eduKansas University Medical Center
Recruiting
Kansas City, Kansas, United States, 66160
Contacts
Halinder S Mangat, MD, MSc
hmangat@braintrauma.orgUniversity of Texas Southwestern Medical Center
Recruiting
Dallas, Texas, United States, 75390
Contacts
Alex Valadka, MD
alex.valadka@utsouthwestern.eduAisha Qureshi
Aisha.Qureshi@utsouthwestern.eduBrooke Army Medical Center
Recruiting
Fort Sam Houston, Texas, United States, 78234
Contacts
Geoffrey Peitz, MD
geoffrey.w.peitz.mil@health.milRyan Morton, MD
ryan.p.morton.mil@health.milUniversity of Houston Medical Center
Recruiting
Houston, Texas, United States, 77030
University of Texas
Recruiting
San Antonio, Texas, United States, 78249
Contacts
Michael McGinity, MD
mcginity@uthscsa.eduMegan Jackson
jacksonm1@uthscsa.eduSponsor
Brain Trauma Foundation
Last update posted
Apr 22, 2026
Last verified
Apr, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brain Trauma Foundation on 2026-04-22.