Clinical trial 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 study wants to find out whether placing an external lumbar drain is safe and feasible for patients with severe brain injury and certain brain scan findings.
- Who it's for
- Adults who have severe traumatic brain injury, open basal cisterns on imaging, and a midline shift of less than 5 mm.
- What's involved
- All participants receive standard care; those in the study group also get an external lumbar drain to remove cerebrospinal fluid, with monitoring for any worsening neurologic signs.
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 is enrolling
- 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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at 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 enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.