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: 0

Duration: 10 days

30 Participants Needed

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}

Research Team

Halinder S Mangat, MD MSc

Principal Investigator

Brain Trauma Foundation; Kansas University Medical Center Research Institute

Jamshid Ghajar, MD PhD

Principal Investigator

Brain Trauma Foundation

Bradley Dengler, MD

Principal Investigator

Military Traumatic Brain Injury Initiative, Uniformed Services University

Gregory Hawryluk, MD PhD

Principal Investigator

Cleveland Clinic Foundation, Brain Trauma Foundation

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

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

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

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+

Findings from Research

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 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 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]

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 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]

References

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

External Lumbar Drainage following Traumatic Intracranial Hypertension: A Systematic Review and Meta-Analysis. [2022]

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]

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]

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]

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

Three-day CSF drainage barely reduces ventricular size in normal pressure hydrocephalus. [2012]

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]

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]