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

Description

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

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Study Overview

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Study Details

Study overview

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.

External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial

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

Condition
Severe Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Kansas City

Kansas University Medical Center, Kansas City, Kansas, United States, 66160

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Fort Sam Houston

Brooke Army Medical Center, Fort Sam Houston, Texas, United States, 78234

San Antonio

University of Texas, San Antonio, Texas, United States, 78249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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
  • 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brain Trauma Foundation,

Halinder S Mangat, MD MSc, PRINCIPAL_INVESTIGATOR, Brain Trauma Foundation; Kansas University Medical Center Research Institute

Jamshid Ghajar, MD PhD, PRINCIPAL_INVESTIGATOR, Brain Trauma Foundation

Gregory Hawryluk, MD PhD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Foundation, Brain Trauma Foundation

Bradley Dengler, MD, STUDY_CHAIR, Military Traumatic Brain Injury Initiative, Uniformed Services University

Study Record Dates

2025-06-30