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

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

Interventions

PROCEDURE

External Lumbar drainage

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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences

  collaborator FED

• University of Kansas

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Brain Trauma Foundation

  lead OTHER

Principal Investigators

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

• Jamshid Ghajar, MD PhD · Brain Trauma Foundation

• Gregory Hawryluk, MD PhD · Cleveland Clinic Foundation, Brain Trauma Foundation

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-24

Primary Completion

2028-06-15

Completion

2028-06-30

Countries

• United States

Study Locations