External Lumbar Drainage for Traumatic Brain Injury

(ELASTIC Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Halinder S Mangat, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brain Trauma Foundation

Must not be taking: Anticoagulants, Anti-thrombotics

Disqualifiers: Pregnancy, Prisoners, Severe spinal deformity, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using anticoagulants or anti-thrombotics, you may not be eligible to participate.

What data supports the effectiveness of the treatment External Lumbar Drainage for Traumatic Brain Injury?

Research shows that external lumbar drainage (ELD) can significantly reduce high intracranial pressure (ICP) in patients with traumatic brain injury, as seen in a study where ICP decreased from 33.7 to 12.5 mmHg after ELD. This suggests ELD may be an effective option for managing high ICP when other treatments are not effective. ^{1 2 3 4 5}

Is external lumbar drainage generally safe for humans?

External lumbar drainage (ELD) has been studied for various conditions, including traumatic brain injury and hydrocephalus, and is generally considered safe. However, like any medical procedure, it may have risks and complications, which should be discussed with a healthcare provider. ^{1 2 4 5 6}

How is external lumbar drainage different from other treatments for traumatic brain injury?

External lumbar drainage (ELD) is unique because it involves draining cerebrospinal fluid (CSF) from the lower back to reduce high intracranial pressure (ICP) that doesn't respond to standard treatments. This method is particularly considered when high ICP is due to issues with CSF flow, offering an alternative when other therapies fail. ^{1 2 3 4 7}

Eligibility Criteria

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.

Inclusion Criteria

My treatment started within 24 hours after my injury.

I am between 18 and 65 years old.

Both of your pupils react the same way to light.

Exclusion Criteria

I previously couldn't make my own medical decisions or had instructions to avoid aggressive treatments.

I have undergone a surgery to remove part of my skull.

Prisoners

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive routine usual care, with the study group additionally undergoing external lumbar drainage (ELD) for cerebrospinal fluid (CSF) drainage.

10 days

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the occurrence of herniation events or death.

4 weeks

Treatment Details

Interventions

• External Lumbar drainage (Procedure)

Trial Overview 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.

Participant Groups

Group I: 2nd stage - treatment Experimental Treatment 1 Intervention

External lumbar drainage @20mmHg if / when intracranial pressure \>20mmHg and tier 1 therapies cannot achieve ICP\<20mmHg

Group II: 1st stage - prophylactic Experimental Treatment 1 Intervention

External lumbar drainage @15mmHg if intracranial pressure is not raised on admission

Group III: Usual treatment Active Control 1 Intervention

Usual treatment as per SIBICC algorithm

External Lumbar drainage is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as External Lumbar Drainage for:

• Severe Traumatic Brain Injury (TBI) with intracranial hypertension

🇪🇺 Approved in European Union as External Lumbar Drainage for:

• Severe Traumatic Brain Injury (TBI) with intracranial hypertension

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kansas University Medical Center Kansas City, KS

University of Texas Southwestern Medical Center Dallas, TX

Brooke Army Medical Center Fort Sam Houston, TX

University of Texas San Antonio, TX

More Trial Locations

Who Is Running the Clinical Trial?

Brain Trauma Foundation Lead Sponsor

The Cleveland Clinic Collaborator

Weill Medical College of Cornell University Collaborator

Uniformed Services University of the Health Sciences Collaborator

University of Kansas Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

External Lumbar Drainage following Traumatic Intracranial Hypertension: A Systematic Review and Meta-Analysis. [2022] Traumatic brain injury (TBI) often results in elevations in intracranial pressure (ICP) that are refractory to standard therapies. Several studies have investigated the utility of external lumbar drainage (ELD) in this setting.

2. Austria pubmed.ncbi.nlm.nih.gov

CSF Lumbar Drainage: A Safe Surgical Option in Refractory Intracranial Hypertension Associated with Acute Posttraumatic External Hydrocephalus. [2022] External lumbar drainage (ELD) of cerebrospinal fluid (CSF) in posttraumatic refractory intracranial hypertension (ICHT) is controversial. We report our experience of ELD in ICHT associated with acute disturbance of CSF flow within subarachnoid spaces (SASs).

3. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients with post-traumatic refractory high intracranial pressure treated with lumbar drainage. [2019] Drainage of cerebrospinal fluid by means of external lumbar drainage (ELD) is controversial in the adult population with traumatic brain injury. We report our experience with ELD in the treatment of post-traumatic high intracranial pressure (ICP) and the results of the long-term follow-up in these patients. We undertook clinical evaluation of 30 patients with traumatic brain injury and high ICP treated with second-tier measures or with first-tier measures if second-tier measures were contraindicated. The study involved a retrospective review of collected data. Outcome at intensive care unit discharge and three to five years after injury were evaluated with the Glasgow Outcome Scale. The mean age of patients was 34.9 +/- 12.5 years and 25 (83%) were male. The median (interquartile range) Glasgow Coma score was 8 (7 to 10). ICP before and one hour after ELD placement was 33.7 +/- 9.0 and 12.5 +/- 4.8 mmHg respectively, a decrease in 21.2 +/- 8.3 mmHg (P

4. Austria pubmed.ncbi.nlm.nih.gov

Using external lumbar CSF drainage to treat communicating external hydrocephalus in adult patients after acute traumatic or non-traumatic brain injury. [2018] Despite various treatments to control intracranial pressure (ICP) after brain injury, patients may present a late onset of high ICP or a poor response to medications. External lumbar drainage (ELD) can be considered a therapeutic option if high ICP is due to communicating external hydrocephalus. We aimed at describing the efficacy and safety of ELD used in a cohort of traumatic or non-traumatic brain-injured patients.

5. United States pubmed.ncbi.nlm.nih.gov

Three-day CSF drainage barely reduces ventricular size in normal pressure hydrocephalus. [2012] External lumbar drainage (ELD) of CSF is a test to determine the suitability of a shunt for patients with normal pressure hydrocephalus (NPH), but its effect on ventricular volume is not known. This study investigates the effect of 3-day ELD of 500 mL on ventricular size and clinical features in patients with idiopathic NPH.

6. Turkey pubmed.ncbi.nlm.nih.gov

Choice for the removal of bloody cerebrospinal fluid in postcoiling aneurysmal subarachnoid hemorrhage: external ventricular drainage or lumbar drainage? [2022] External ventricular drainage (EVD) and lumbar drainage (LD) are the most widely used procedures for continued bloody cerebrospinal fluid drainage. Each has his own advantages and disadvantages. Here, we compared complications and clinical outcomes in patients with World Federation of Neurosurgical Societies (WFNS) grade III aneurysmal subarachnoid hemorrhage (aSAH) who underwent coil placement followed by EVD or LD.

7. Austria pubmed.ncbi.nlm.nih.gov

External lumbar drainage in uncontrollable intracranial pressure in adults with severe head injury: a report of 7 cases. [2019] The retrospective results of external lumbar drainage in 7 adult patients with severe closed head injury and intracranial pressure (ICP) refractory to aggressive management strategies are presented. All patients had Glasgow Coma Scale (GCS) scores of 8 or less within 24 hours after admission and were treated by a staircase protocol including sedation, ventricular drainage, hyperventilation and mannitol. In three cases barbiturate drugs and an artificially induced hypothermia were used. Four patients required surgical evacuation of mass lesions. Three patients made a good functional recovery, 2 were severely disabled and 2 patients died. In none of the patients clinical signs of cerebral herniation occurred. We recommend additional external lumbar drainage in adults with severe head injury unresponsive to aggressive ICP control with open basilar cisterns and absent focal mass lesions on computerized-tomography scan before drainage.