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Brain bleed breakthrough? massive study tests surgery vs. standard care

NCT ID NCT05975398

Knowledge-focused Sponsor: Beijing Tiantan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This large registry study tracks 2,000 adults in China with severe spontaneous brain hemorrhage to compare outcomes of emergency surgery versus conservative (non-surgical) treatment. It focuses on patients who take long-term antiplatelet drugs (like aspirin) to see if surgery is safe and effective for them. Researchers also monitor complications like bleeding after surgery and disorders of consciousness. The goal is to generate real-world evidence to guide treatment decisions for this life-threatening condition.

What this could mean

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

What this could lead to
If successful, this could clarify whether emergency surgery saves more lives than standard care for severe brain bleeds, particularly in patients on blood thinners.
What could go wrong
This is an observational registry, not a controlled experiment, so results may show associations but not prove cause and effect. Findings may not apply outside China.

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.

Participants

About 2,000 people

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

Started

Nov 2019

Expected to finish

Dec 2030

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.

Who is studied

Patients with spontaneous, nontraumatic intracerebral hemorrhage enrolled in the ongoing CRISIH registry at participating clinical centers in China, receiving surgical or conservative management according to clinical indications and routine clinical practice. Severe spontaneous intracerebral hemorrhage (SSICH) is defined as supratentorial hematoma volume \>30 mL, infratentorial hematoma volume \>10 mL, midline shift \>1 cm, large intraventricular hematoma, or Glasgow Coma Scale (GCS) score \<13.

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: 1. Age 18 years or older. 2. Spontaneous, nontraumatic intracerebral hemorrhage. 3. Treatment with surgical or conservative management according to clinical indications and routine clinical practice. 4. Written informed consent provided by the patient or legally authorized representative/family member. Exclusion Criteria: 1. Patients had cerebrovascular diseases associated with hemorrhage, such as intracranial aneurysm, cerebrovascular malformation, or intracranial tumors. 2. Hemorrhagic transformation of cerebral infarction. 3. Hemorrhage caused by cerebral venous thrombosis. 4. Patients with severe coagulation disorder, such as hemophilia. 5. Patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, or related conditions. 6. Patients receiving other anticoagulation medications, including vitamin K antagonists or novel oral anticoagulants. 7. Patients who died before arrival at the hospital, on arrival at the hospital, or within a short period (6 hours) after admission.

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Conditions

The condition(s) this trial relates to.

Consciousness Disorders intracerebral hemorrhage

As listed by the trial registrant

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

Complications Disorders of consciousness Emergency surgery Long-term antiplatelet treatment Severe spontaneous intracranial hemorrhage

How to take part

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

  1. The places running it

    1 site. 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

  • Capital Medical University Affiliated Beijing Tiantan Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

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