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Could a back drain save brain bleed patients from a lifetime shunt?

NCT ID NCT06510842

Disease control Sponsor: University Hospital Heidelberg 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at people who have a brain bleed that also fills the fluid spaces inside the brain, causing dangerous pressure. Normally, doctors place a drain in the head to remove fluid. This trial adds a second drain in the lower back to see if it helps patients recover better and avoid needing a permanent tube (shunt) later. About 354 adults will take part, and the goal is to improve function and reduce long-term complications.

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 354 people

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

Started

Jan 2025

Expected to finish

Jul 2029

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 years and older

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: * ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus * Age ≥ 18 y * Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well Exclusion Criteria: * Premorbid mRS score \> 2 * Pregnancy * Life expectancy \<6 months * Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures. * Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted. * Other clear contraindication for treatment with a lumbar drain

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage

As listed by the trial registrant

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

External ventricular drainage Intraventricular hemorrhage Lumbar drainage

How to take part

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

  1. The places running it

    12 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

  • Augsburg University Hospital

    RECRUITING

    Augsburg, Germany

  • Augsburg University Hospital Department of Neurosurgery

    RECRUITING

    Heidelberg, Germany

  • Charite Universitätsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, Germany

  • Department of Neurology, University Hospital Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Düsseldorf Universitiy Hospital

    RECRUITING

    Düsseldorf, Germany

  • Frankfurt University Hospital

    NOT_YET_RECRUITING

    Frankfurt, Germany

  • Goettingen University Hospital

    NOT_YET_RECRUITING

    Göttingen, Germany

  • Heidelberg University Hospital Department of Neurosurgery

    RECRUITING

    Heidelberg, Germany

  • LMU München

    RECRUITING

    München, Bavaria, Germany

  • Mainz University Hospital

    NOT_YET_RECRUITING

    Mainz, Germany

  • Mannheim University Hospital

    RECRUITING

    Mannheim, Germany

  • Osnabrück Clinic

    RECRUITING

    Osnabrück, Germany

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