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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrain Trauma Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years age

Glasgow Coma Scale (GCS) 3-8

Pupils symmetric and bilaterally reactive

Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT

Disqualifiers

GCS >8

Cisterns on CT completely effaced

Midline shift on CT >5mm

GCS 3 with dilated and fixed pupils

Trial design

Design model

Sequential

Treatments tested in this trial

  • External Lumbar drainage

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: 1st stage - prophylacticExperimental treatment 1 intervention
Group B: 2nd stage - treatmentExperimental treatment 1 intervention
Group C: Usual treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Safety of ELD in selected Severe TBI patients

Rate of occurrence of herniation events or death in 3 arms

Time frame
10 days
2

Feasibility of ELD in selected Severe TBI patients

Proportion of patients able to undergo treatment as per randomised arm

Time frame
10 days

Secondary outcomes

1

Reduction in ICP burden using ELD in selected severe TBI patients

Total number of hours with ICP\>20mmHg

Time frame
10 days
2

Utility of automated pupillometry to predict safety of ELD

worsening of Pupillometry based reactivity index in 6 hours preceding herniation events with occurrence of such events

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brain Trauma Foundation

Lead sponsor

Uniformed Services University of the Health Sciences

Collaborator

University of Kansas

Collaborator

The Cleveland Clinic

Collaborator

Weill Medical College of Cornell University

Collaborator