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New treatment option for Severe Traumatic Brain Injury
Official title External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
ClinicalTrials.gov ID: NCT05889650
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 18-65 years age
- Glasgow Coma Scale (GCS) 3-8
- Pupils symmetric and bilaterally reactive
- Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
- Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
You likely can't join if
- GCS \>8
- Cisterns on CT completely effaced
- Midline shift on CT \>5mm
- GCS 3 with dilated and fixed pupils
- Uncal or tonsillar herniation on admission or post-operative brain CT
- Temporal lobe contusions with effaced ipsilateral cisterns
See the full eligibility criteria
- 18-65 years age
- Glasgow Coma Scale (GCS) 3-8
- Pupils symmetric and bilaterally reactive
- Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
- Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
- First randomization and intervention may be commenced within 24 hours of injury
- ELD safety score ≥5
- GCS \>8
- Cisterns on CT completely effaced
- Midline shift on CT \>5mm
- GCS 3 with dilated and fixed pupils
- Uncal or tonsillar herniation on admission or post-operative brain CT
- Temporal lobe contusions with effaced ipsilateral cisterns
- Penetrating TBI
- Primary hemicraniectomy
- Pregnancy
- Prisoners
- Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
- Pre-existing conditions affecting functional status or life expectancy to less than 1 year
- Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity.
- posterior fossa hemorrhage
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Kansas City, Kansas, United States
- Dallas, Texas, United States
- Fort Sam Houston, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Kansas City, Kansas, United States; Dallas, Texas, United States; Fort Sam Houston, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.