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Procedure

External Lumbar Drainage for Traumatic Brain Injury (ELASTIC Trial)

N/A
Recruiting
Led By Gregory Hawryluk, MD PhD
Research Sponsored by Brain Trauma Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years age
Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
Must not have
Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
Primary hemicraniectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
No Placebo-Only Group

Summary

This trial explores if ELD is safe & feasible for severe TBI patients without increasing risk of neurological worsening or herniation. Researchers will compare groups to see effects on raised intracranial pressure.

Who is the study for?
This trial is for adults aged 18-65 with severe Traumatic Brain Injury (TBI), who are minimally conscious or worse, have a certain level of brain shift on CT scans, and can start treatment within a day of injury. It's not for those with mild TBI, pregnancy, prisoners, life expectancy less than a year due to other conditions, specific types of herniation or contusions in the brain, penetrating TBI, previous incapacity to consent/refuse treatment or advanced directives against aggressive care.
What is being tested?
The study tests if using External Lumbar Drainage (ELD) alongside usual care is safe and doable for draining excess cerebrospinal fluid in patients with severe TBI. Participants will be randomly assigned to receive either standard treatment alone or standard treatment plus ELD. The main focus is on whether ELD increases risks like neurological worsening or cerebral herniation.
What are the potential side effects?
While the side effects aren't detailed here since it's an early-phase trial focused on safety and feasibility; potential risks may include infection at the drainage site, headache from CSF pressure changes, back pain where the drain was inserted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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My brain scans show open quadrigeminal cisterns.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I previously couldn't make my own medical decisions or had instructions to avoid aggressive treatments.
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I have undergone a surgery to remove part of my skull.
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I have bruises on the brain's temporal lobe.
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I don't have bleeding disorders, take blood thinners, have very low platelets, or severe spine issues.
Select...
I have had a penetrating brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of ELD in selected Severe TBI patients
Safety of ELD in selected Severe TBI patients
Secondary study objectives
Reduction in ICP burden using ELD in selected severe TBI patients
Utility of automated pupillometry to predict safety of ELD

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2nd stage - treatmentExperimental Treatment1 Intervention
External lumbar drainage @20mmHg if / when intracranial pressure \>20mmHg and tier 1 therapies cannot achieve ICP\<20mmHg
Group II: 1st stage - prophylacticExperimental Treatment1 Intervention
External lumbar drainage @15mmHg if intracranial pressure is not raised on admission
Group III: Usual treatmentActive Control1 Intervention
Usual treatment as per SIBICC algorithm

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,730 Total Patients Enrolled
1 Trials studying Intracranial Hypertension
16 Patients Enrolled for Intracranial Hypertension
Weill Medical College of Cornell UniversityOTHER
1,092 Previous Clinical Trials
1,154,756 Total Patients Enrolled
1 Trials studying Intracranial Hypertension
20 Patients Enrolled for Intracranial Hypertension
Brain Trauma FoundationLead Sponsor
3 Previous Clinical Trials
593 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
124 Previous Clinical Trials
90,723 Total Patients Enrolled
1 Trials studying Intracranial Hypertension
50 Patients Enrolled for Intracranial Hypertension
University of KansasOTHER
154 Previous Clinical Trials
331,672 Total Patients Enrolled
Bradley Dengler, MDStudy ChairMilitary Traumatic Brain Injury Initiative, Uniformed Services University
Gregory Hawryluk, MD PhDPrincipal InvestigatorCleveland Clinic Foundation, Brain Trauma Foundation
Bradley DenglerStudy ChairMilitary Traumatic Brain Injury Initiative, Uniformed Services University
Halinder S Mangat, MD MScPrincipal InvestigatorBrain Trauma Foundation; Kansas University Medical Center Research Institute
Jamshid Ghajar, MD PhDPrincipal InvestigatorBrain Trauma Foundation

Media Library

Intracranial Hypertension Research Study Groups: 1st stage - prophylactic, Usual treatment, 2nd stage - treatment
~14 spots leftby Jun 2025
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