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Spinal drain may ease brain pressure after severe head trauma

NCT ID NCT05889650

Disease control Sponsor: Brain Trauma Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether draining fluid from the spine (external lumbar drainage) is safe and doable for people with severe traumatic brain injury who have high pressure inside the skull. Thirty adults aged 18-65 will receive either standard care alone or standard care plus the spinal drain. The main goal is to see if the procedure increases the risk of brain herniation or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
External lumbar drainage (a procedure to drain fluid from the spine)
What this could lead to
If successful, this could provide a new way to safely lower brain pressure in severe head injury patients, potentially reducing complications.
What could go wrong
This is a very early, small safety trial with only 30 participants. The procedure carries risks like brain herniation or neurological worsening, and it may not prove effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic intracranial hypertension traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial hypertension Severe traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brooke Army Medical Center

    RECRUITING

    Fort Sam Houston, Texas, 78234, United States

  • Kansas University Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Houston Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas

    RECRUITING

    San Antonio, Texas, 78249, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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