Evaluating emergency surgery for severe brain hemorrhage patients on long-term antiplatelet treatment
China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
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 |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05975398 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with underlying cerebrovascular diseases, tumors, or severe coagulation disorders are unlikely to benefit from this study.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) 18-75 years old; * (2) non-traumatic intracerebral hemorrhage; * (3) severe intracerebral hemorrhage, which was defined as patients with supratentorial bleeding volume \> 30 ml, infratentorial bleeding volume \> 10 ml, midline shift \> 1 cm, or large intraventricular hematoma; * (4) Glasgow coma score (GCS) \< 13; * (5) family members agree to provide an informed written consent. Exclusion Criteria: * (1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors, which were associated with hemorrhage; * (2) hemorrhagic transformation of cerebral infarction; * (3) hemorrhage caused by venous thrombosis; * (4) patients with severe coagulation disorder, e.g., hemophilia; * (5) patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on; * (6) patients receiving other anticoagulation medications (vitamin K antagonist and new oral anticoagulants); * (7) patients not on LOAPT who receive conservative treatment; * (8) the patients who died before or on arriving at the hospital and within a short period (6 h) after admission.
Where this trial is running
Beijing, Beijing
- Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shuo Wang
- Email: captain9858@126.com
- Phone: +86 13801180330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.