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External Lumbar Drainage for Traumatic Brain Injury (ELASTIC Trial)

Q: Are individuals aged 30 or older being recruited for this clinical experiment?

Eligible participants for this study must be of legal age (18 or over) and under 65 years old.

Q: Who has the necessary qualifications to participate in this research endeavor?

This clinical trial seeks 30 candidates to participate who are aged 18-65 and have intracranial <a href="https://www.withpower.com/clinical-trials/hypertension">hypertension</a>.

Q: Is there any availability to join this research endeavor?

According to clinicaltrials.gov, this specific trial is not presently enlisting new participants as it was first posted on September 1st 2023 and last updated June 1st 2023. Nevertheless, there are 1064 other similar trials currently taking in patients.

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

ELASTIC Trial 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.Check my eligibility

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.See study design

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.

ELASTIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

My brain scans show open quadrigeminal cisterns.

ELASTIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of ELD in selected Severe TBI patients

Safety of ELD in selected Severe TBI patients

Secondary outcome measures

Reduction in ICP burden using ELD in selected severe TBI patients

Utility of automated pupillometry to predict safety of ELD

ELASTIC 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER

1,027 Previous Clinical Trials

1,364,248 Total Patients Enrolled

1 Trials studying Intracranial Hypertension

16 Patients Enrolled for Intracranial Hypertension

Weill Medical College of Cornell UniversityOTHER

1,054 Previous Clinical Trials

1,316,522 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

Media Library

Intracranial Hypertension Research Study Groups: 1st stage - prophylactic, Usual treatment, 2nd stage - treatment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 30 or older being recruited for this clinical experiment?

"Eligible participants for this study must be of legal age (18 or over) and under 65 years old."

Answered by AI

Who has the necessary qualifications to participate in this research endeavor?

"This clinical trial seeks 30 candidates to participate who are aged 18-65 and have intracranial hypertension."

Answered by AI

Is there any availability to join this research endeavor?

"According to clinicaltrials.gov, this specific trial is not presently enlisting new participants as it was first posted on September 1st 2023 and last updated June 1st 2023. Nevertheless, there are 1064 other similar trials currently taking in patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Halinder Mangat 2023. "External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889650.

All > Intracranial Hypertension