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

External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These events will be recorded for all patients and prompt treatment will be instituted accordingly, including an emergent computed tomography (CT) scan (36)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests whether draining fluid through a tube in the lower back is safe and practical for adults with severe brain injury from trauma and certain brain scan findings. It compares usual care plus drainage with usual care alone to see whether drainage lowers pressure inside the skull without causing brain function to worsen or brain tissue to shift dangerously.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–65.
  • A Glasgow Coma Scale score of 3–8, showing a very low level of alertness.
  • Pupils are the same size, and both respond to light.
  • A brain CT scan at admission or after surgery shows the brain's center has shifted no more than 5 mm at the required location.
  • The same scan shows certain fluid spaces near the back of the brain are fully or partly open.
  • Study group assignment and treatment can start within 24 hours of injury.
  • A lumbar drainage safety score of at least 5.

Who can't join

  • An alertness score above 8, or a score of 3 with large pupils that do not respond to light.
  • Brain scans show fully closed fluid spaces, a shift of more than 5 mm, or brain tissue pushed dangerously downward.
  • Bruising in the brain's side region with closed fluid spaces on that side, or bleeding in the lower back part of the skull.
  • An injury that pierces the skull and enters the brain, or initial surgery to remove a large section of one side of the skull.
  • Pregnant or a prisoner.
  • Already unable to agree to or refuse treatment before the injury, or written instructions to avoid aggressive care.
  • Existing health problems that affect daily function or limit expected survival to less than one year.
  • Conditions that prevent safe drain placement: a blood-clotting disorder, use of medicines that prevent clots, a platelet count below 50,000 (platelets help blood clot), or a severely misshapen spine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 18-65 years age 2. Glasgow Coma Scale (GCS) 3-8 3. Pupils symmetric and bilaterally reactive 4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT 5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT 6. First randomization and intervention may be commenced within 24 hours of injury 7. ELD safety score ≥5 Exclusion Criteria: 1. GCS \>8 2. Cisterns on CT completely effaced 3. Midline shift on CT \>5mm 4. GCS 3 with dilated and fixed pupils 5. Uncal or tonsillar herniation on admission or post-operative brain CT 6. Temporal lobe contusions with effaced ipsilateral cisterns 7. Penetrating TBI 8. Primary hemicraniectomy 9. Pregnancy 10. Prisoners 11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care 12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year 13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity. 14. posterior fossa hemorrhage

Study sites (6)

FL

KS

TX