External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Brain Trauma Foundation
Study ID
NCT05889650
Status
Recruiting
Apply to this trial

Conditions

  • Intracranial Hypertension
  • Severe Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • External Lumbar drainage — PROCEDURE
    ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage

Study Details

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 \<5mm without increasing the risk of neurological worsening or cerebral herniation. All 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.

Key Dates

Start date
Jun 24, 2024
Status verified
Apr 2026
Primary completion
Jun 15, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1st stage - prophylactic
    External lumbar drainage @15mmHg if intracranial pressure is not raised on admission
  • Experimental: 2nd stage - treatment
    External lumbar drainage @20mmHg if / when intracranial pressure \>20mmHg and tier 1 therapies cannot achieve ICP\<20mmHg
  • No Intervention: Usual treatment
    Usual treatment as per SIBICC algorithm

Primary Outcome Measure

Safety of ELD in selected Severe TBI patients [ Time Frame: 10 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Ivan DaSilva, MD
[email protected]
Magali Jorand-Fletcher
[email protected]
Kansas University Medical CenterKansas CityKansas66160
Halinder S Mangat, MD, MSc
[email protected]
University of Texas Southwestern Medical CenterDallasTexas75390
Alex Valadka, MD
[email protected]
Aisha Qureshi
[email protected]
Brooke Army Medical CenterFort Sam HoustonTexas78234
Geoffrey Peitz, MD
[email protected]
Ryan Morton, MD
[email protected]
University of Houston Medical CenterHoustonTexas77030
Ryan Kitagawa, MD, PhD
University of TexasSan AntonioTexas78249
Michael McGinity, MD
[email protected]
Megan Jackson
[email protected]

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FLKansas University Medical Center· Kansas City, KSUniversity of Texas Southwestern Medical Center· Dallas, TXBrooke Army Medical Center· Fort Sam Houston, TXUniversity of Houston Medical Center· Houston, TXUniversity of Texas· San Antonio, TX

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