Recruiting

External Lumbar Drainage

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

Study Details

Brief summary:

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.

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

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18-65 years age
2. Glasgow Coma Scale (GCS) 3-8
3. Pupils symmetric and bilaterally reactive
4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
6. First randomization and intervention may be commenced within 24 hours of injury
7. ELD safety score ≥5

Exclusion Criteria:

1. GCS >8
2. Cisterns on CT completely effaced
3. Midline shift on CT >5mm
4. GCS 3 with dilated and fixed pupils
5. Uncal or tonsillar herniation on admission or post-operative brain CT
6. Temporal lobe contusions with effaced ipsilateral cisterns
7. Penetrating TBI
8. Primary hemicraniectomy
9. Pregnancy
10. Prisoners
11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year
13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia <50,000, or severe spinal deformity.
14. posterior fossa hemorrhage

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

External Lumbar drainage

ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Kansas University Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Halinder S Mangat, MD, MSc

hmangat@braintrauma.org

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

University 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.edu

More Information

Sponsor

Brain Trauma Foundation

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Traumatic brain injury
  • intracranial pressure
  • intracranial hypertension
  • lumbar drainage

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.