External Lumbar Drainage for Traumatic Brain Injury

(ELASTIC Trial)

Recruiting at 4 trial locations

Overseen By Halinder S Mangat, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brain Trauma Foundation

Must not be taking: Anticoagulants, Anti-thrombotics

Disqualifiers: Pregnancy, Prisoners, Severe spinal deformity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether draining fluid from the lower back is safe and feasible for individuals with severe traumatic brain injuries (TBIs). It examines if this method, known as External Lumbar Drainage (ELD), can aid recovery without worsening brain conditions. Participants will receive standard care, with some also trying this new fluid drainage technique to assess its impact on brain pressure. Individuals who recently experienced a severe TBI, as indicated by specific brain scans and symptoms, might qualify. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future TBI treatments.

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 prior data suggests that external lumbar drainage is safe for patients with traumatic brain injury?

Research has shown that external lumbar drainage (ELD) might be safe for individuals with severe traumatic brain injury (TBI). Studies report a low risk of serious issues such as cerebral herniation, where brain tissue shifts out of place, or meningitis, an infection of the brain's protective layers.

One study found that ELD can help control high pressure inside the skull without causing major side effects, making it a potential option when other treatments fail. While the data is promising, each person's situation is unique. Always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about external lumbar drainage for traumatic brain injury because it offers a new approach to managing intracranial pressure. Unlike the standard treatments that often involve medications or surgical procedures, this technique involves draining cerebrospinal fluid through a small tube in the lower back to help relieve pressure on the brain. The drainage can be adjusted based on the patient's needs, providing a more tailored and potentially quicker response to changing pressure levels compared to traditional methods. This approach could be a game-changer, especially for patients who do not respond well to existing therapies.

What evidence suggests that external lumbar drainage is effective for traumatic brain injury?

This trial will compare external lumbar drainage (ELD) with usual treatment for managing intracranial pressure in patients with severe traumatic brain injury (TBI). Studies have shown that ELD can help control pressure inside the skull. Research indicates that ELD may lower this pressure, which is crucial to prevent further brain damage. A review of existing studies suggests that ELD might be beneficial when other treatments to reduce pressure are insufficient. Specifically, one study found that ELD can safely manage this pressure without causing additional brain problems. Overall, these findings support the potential of ELD to effectively manage the effects of severe TBI. ^{1 2 3 5 6}

Who Is on the Research Team?

Halinder S Mangat, MD MSc

Principal Investigator

Brain Trauma Foundation; Kansas University Medical Center Research Institute

Gregory Hawryluk, MD PhD

Principal Investigator

Cleveland Clinic Foundation, Brain Trauma Foundation

Bradley Dengler, MD

Principal Investigator

Military Traumatic Brain Injury Initiative, Uniformed Services University

Jamshid Ghajar, MD PhD

Principal Investigator

Brain Trauma Foundation

Are You a Good Fit for This Trial?

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.

Both of your pupils react the same way to light.

My brain scans show open quadrigeminal cisterns.

Exclusion Criteria

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

Prisoners

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• External Lumbar drainage

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Brain Trauma Foundation

Lead Sponsor

Trials

4

Recruited

620+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Published Research Related to This Trial

In a study of four adult patients with severe traumatic brain injury and refractory intracranial hypertension, external lumbar drainage (ELD) effectively reduced intracranial pressure from a mean of 37 mmHg to 5 mmHg, demonstrating its efficacy in managing this condition.

The procedure was found to be safe, with no reported complications, suggesting that ELD can be a viable and minimally invasive option for treating acute traumatic hydrocephalus associated with increased intracranial pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CSF Lumbar Drainage: A Safe Surgical Option in Refractory Intracranial Hypertension Associated with Acute Posttraumatic External Hydrocephalus. Manet, R., Schmidt, EA., Vassal, F., et al.[2022]

External lumbar drainage (ELD) significantly reduced intracranial pressure (ICP) in patients with traumatic brain injury, with an average decrease of 21.2 mmHg after placement, indicating its efficacy in managing high ICP.

In the long-term follow-up of 30 patients, 62% achieved favorable outcomes (good recovery or moderate disability), and complications were minimal, with only one case of cerebrospinal fluid infection (3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients with post-traumatic refractory high intracranial pressure treated with lumbar drainage. Llompart-Pou, JA., Abadal, JM., Pérez-Bárcena, J., et al.[2019]

In a study of 15 patients with idiopathic normal pressure hydrocephalus (NPH), external lumbar drainage (ELD) of cerebrospinal fluid (CSF) led to a significant reduction in ventricular size, averaging 3.7 mL, indicating that ELD can effectively reduce ventricular volume.

Despite the reduction in ventricular size, clinical improvements in gait and attention were observed in some patients, suggesting that the benefits of ELD may be more related to the process of CSF drainage rather than the actual change in ventricular volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-day CSF drainage barely reduces ventricular size in normal pressure hydrocephalus. Lenfeldt, N., Hansson, W., Larsson, A., et al.[2012]

In a study of 33 patients with delayed high intracranial pressure (ICP) after brain injury, external lumbar drainage (ELD) significantly reduced ICP from a median of 25 mmHg to 7 mmHg, demonstrating its efficacy in managing this condition.

The procedure was found to be safe, with no major adverse effects reported, except for one case of infection, suggesting that ELD can be a reliable treatment option for patients diagnosed with communicating external hydrocephalus.

NCBI (Pubmed)

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. Manet, R., Payen, JF., Guerin, R., et al.[2018]

External lumbar drainage (ELD) significantly reduces intracranial pressure (ICP) immediately after treatment, with a pooled effect size of -19.5 mmHg based on a meta-analysis of 6 studies involving 110 adults with traumatic brain injury.

While ELD appears to be safe with low rates of complications like cerebral herniation or meningitis, there is limited evidence on its long-term effectiveness and neurological outcomes, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Lumbar Drainage following Traumatic Intracranial Hypertension: A Systematic Review and Meta-Analysis. Badhiwala, J., Lumba-Brown, A., Hawryluk, GWJ., et al.[2022]

In a study of 148 patients with WFNS grade III aneurysmal subarachnoid hemorrhage, lumbar drainage (LD) was associated with a lower incidence of intracerebral hemorrhage compared to external ventricular drainage (EVD).

Patients in the LD group experienced similar outcomes in terms of vasospasm and Glasgow outcome scale scores after 2 months, suggesting that LD may be a safer and equally effective option for managing cerebrospinal fluid drainage in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice for the removal of bloody cerebrospinal fluid in postcoiling aneurysmal subarachnoid hemorrhage: external ventricular drainage or lumbar drainage? Sun, C., Du, H., Yin, L., et al.[2022]

In a study of 7 adult patients with severe closed head injuries and high intracranial pressure (ICP), external lumbar drainage was used as an additional treatment when other methods failed, leading to no signs of cerebral herniation in any patient.

Out of the 7 patients, 3 achieved good functional recovery, while 2 were severely disabled and 2 died, suggesting that while external lumbar drainage can be beneficial, outcomes can vary significantly based on individual circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External lumbar drainage in uncontrollable intracranial pressure in adults with severe head injury: a report of 7 cases. Willemse, RB., Egeler-Peerdeman, SM.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34171100/

External Lumbar Drainage following Traumatic Intracranial ... Objective: To evaluate the safety and efficacy of ELD or lumbar puncture with regard to immediate effect on ICP, durability of the effect on ICP ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05889650

External Lumbar Drainage to Reduce ICP in Severe TBI: a ... This is a randomized controlled trial to determine the safety and feasibility of external lumbar drainage (ELD) of cerebrospinal fluid (CSF) as an adjunct to ...

3. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05199-1

Impact of lumbar cerebrospinal fluid drainage to control ... External lumbar drainage (ELD) of cerebrospinal fluid may help control intracranial pressure following a traumatic brain injury.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560689/

External Lumbar Drainage to Abort Severe Traumatic ... The study will include 30 severe TBI patients with a Glasgow Coma Scale score ≤9 who will be randomized to usual treatment, usual treatment plus ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028377021001570

A review of external lumbar drainage for the management ... The literature suggests that ELD may play a role in the management of refractory ICH in TBI patients when first and second-tier measures fail and may be a safe, ...

6. journals.lww.com journals.lww.com/neurosurgpraconline/fulltext/2025/12000/external_lumbar_drainage_to_abort_severe_traumatic.21.aspx

External Lumbar Drainage to Abort Severe Traumatic... The aim of this study is to evaluate safety and feasibility of controlled CSF ELD in reducing ICP burden and improving outcomes of select severe TBI patients.