Status:
UNKNOWN
China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Beijing Chao Yang Hospital
Beijing Shuyi Hospital
Conditions:
Severe Spontaneous Intracranial Hemorrhage
Long-term Antiplatelet Treatment
Eligibility:
All Genders
18-75 years
Brief Summary
Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe s...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05975398
Start Date
July 1 2022
End Date
December 31 2025
Last Update
November 28 2023
Active Locations (1)
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1
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China