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Draining fluid early after brain bleed may boost recovery

NCT ID NCT07625449

Disease control Sponsor: Second Affiliated Hospital of Nanchang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 1 time

Summary

This trial investigates whether adding early lumbar drainage to standard care (a drain in the head plus clot-dissolving medication) improves long-term outcomes for people with bleeding into the brain's fluid-filled spaces. The study includes adults aged 18 to 85 who have had a first-time brain bleed with ventricular involvement and require a ventricular drain. Participants are randomly assigned to receive either standard care alone or standard care plus early lumbar drainage, and their functional recovery is measured at 90 and 180 days.

What this could mean

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

Active substance
lumbar drainage
What this could lead to
If effective, early lumbar drainage could become a standard addition to treatment, reducing disability and improving recovery after ventricular hemorrhage.
What could go wrong
This is a relatively early-stage trial with 392 participants, and the procedure carries risks such as infection or over-drainage. Results may not apply to all patients.

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 392 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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 to 85 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. Aged 18-85 years, of either sex. 2. First-ever intracerebral hemorrhage (ICH) with CT-confirmed hemorrhage involving the third and/or fourth ventricle, and scheduled to undergo or already having undergone burr-hole ventricular drainage. 3. Intraparenchymal hemorrhage volume \<30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization. 4. Randomization completed within 72 hours of symptom onset. 5. Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities). 6. Written informed consent obtained from the participant or a legal guardian. Exclusion Criteria: 1. Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor. 2. Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase. 3. Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal. 4. Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site). 5. Infratentorial hemorrhage with a volume ≥10 mL. 6. Thalamic hemorrhage with a volume ≥10 mL, or accompanied by obvious extension into the midbrain, oculomotor nerve palsy, or fixed and dilated non-reactive pupils. 7. Unilateral limb paralysis (muscle strength grade 0 or 1) before randomization. 8. Active bleeding from other sites, including the gastrointestinal, genitourinary, or respiratory tracts. 9. Multiple superficial ecchymoses, purpura, or other signs suggesting bleeding or a bleeding tendency. 10. Expected survival of less than 6 months due to other causes. 11. Other coexisting severe diseases that are difficult to treat. 12. Pregnancy. 13. Participation in another interventional clinical trial within 30 days before randomization. 14. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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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.

Cerebral hemorrhage Intraventricular hemorrhage

How to take part

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

  1. The places running it

    31 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

  • Changde First People's Hospital

    Changde, China

  • Fuzhou First People's Hospital

    Fuzhou, Jiangxi, China

  • Ganzhou People's Hospital

    Ganzhou, China

  • Ji'an Central People's Hospital

    Ji’an, China

  • Jinan Central Hospital

    Jinan, Shandong, China

  • Jingdezhen Second People's Hospital

    Jingdezhen, China

  • Jiujiang First People's Hospital

    Jiujiang, China

  • Lingcheng District People's Hospital

    Dezhou, China

  • Linyi People's Hospital

    Linyi, China

  • Nanchang Central Hospital

    Nanchang, China

  • Panzhihua Central Hospital

    Panzhihua, China

  • Qilu Hospital of Shandong University Dezhou Hospital

    Dezhou, China

  • Ruijin People's Hospital

    Ganzhou, China

  • Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • Taihe Hospital

    Shiyan, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, China

  • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

    Suzhou, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, China

  • The First People's Hospital of Xiushui County

    Jiujiang, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The Second Hospital of Lanzhou University

    Lanzhou, China

  • Yichang Central People's Hospital

    Yichang, China

  • Yingtan People's Hospital

    Yingtan, China

  • Zhangjiagang First People's Hospital

    Zhangjiagang, China

  • Zhangshu People's Hospital

    Yichun, China

  • Zhoukou Central Hospital

    Zhoukou, China

  • Zunyi First People's Hospital

    Zunyi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.