Evaluating emergency surgery for severe brain hemorrhage patients on long-term antiplatelet treatment
Official title: China Research for Severe Spontaneous Intracerebral Hemorrhage(CRISIH)
Run by Beijing Tiantan Hospital · NCT05975398 · Data updated 2026-11-12
This study is trying to see if emergency surgery can help people with severe brain bleeding who are taking blood-thinning medications and how safe it is for them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | November 1, 2019 |
| Main results expected | December 30, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT05975398 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-75 with severe non-traumatic intracerebral hemorrhage and a Glasgow coma score of less than 13.
✕Probably not a fit
Patients with underlying cerebrovascular diseases, tumors, or severe coagulation disorders are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to assess the effects and safety of emergency surgery in patients suffering from severe spontaneous intracerebral hemorrhage (SSICH) who are on long-term oral antiplatelet treatment. Conducted across seven clinical centers, the study will recruit 450 patients and monitor them for clinical, radiological, and laboratory outcomes until death or six months post-hemorrhage. The study began in September 2019 and is set to conclude in December 2022, focusing on understanding the implications of surgical intervention in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and efficacy of emergency surgical interventions for patients with severe brain hemorrhages who are on antiplatelet therapy.
How similar studies have gone: While the specific approach of this study may be novel, similar studies have indicated the importance of understanding surgical outcomes in patients with complex medical histories.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Shuo Wang
- Email: captain9858@126.com
- Phone: +86 13801180330
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.