NCT05975398 China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
| NCT ID | NCT05975398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Severe Spontaneous Intracranial Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2019-11-01 |
| Primary Completion | 2029-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2019-11-01 with a primary completion date of 2029-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Although emergency surgery may reduce mortality in patients with severe spontaneous intracerebral hemorrhage (SSICH), the effectiveness and safety of surgical treatment among SSICH patients receiving long-term oral antiplatelet therapy (LOAPT) remain unclear. The CRISIH registry was originally designed to evaluate the effect and safety of emergency surgery in SSICH patients receiving LOAPT and has subsequently continued as an ongoing multicenter registry of spontaneous intracerebral hemorrhage. Methods: The CRISIH registry is an ongoing prospective, multicenter cohort registry conducted across participating clinical centers in China. The registry was initiated in November 2019 and is designed as a 10-year registry with continued recruitment and follow-up. Data from the initial five-year enrollment period are used for interim and secondary analyses, while recruitment and follow-up continue during the subsequent registry period. Clinical, radiological, surgical, laboratory, and follow-up information are collected using standardized case report forms. For the originally registered primary outcome, patients are followed until death or 6 months after the occurrence of primary hemorrhage; selected follow-up assessments and secondary analyses may extend beyond this period according to the registry protocol. Study Design: The CRISIH registry was designed as a prospective, multicenter cohort registry of patients with spontaneous intracerebral hemorrhage. One originally registered comparative focus evaluates SSICH patients receiving LOAPT, comparing total mortality and survival outcomes between patients receiving emergency surgical treatment and those receiving conservative treatment. The safety of surgery is assessed by comparing postoperative hemorrhagic complications among operated patients with and without LOAPT. Based on the observed clinical characteristics and outcomes of patients receiving LOAPT, the registry also evaluates ischemic events after discontinuation of LOAPT and explores coagulation function assessment strategies in operated patients receiving LOAPT. Objective: The CRISIH registry aims to prospectively evaluate clinical outcomes and management strategies in patients with spontaneous intracerebral hemorrhage. An originally registered focus of the registry is to assess the effectiveness and safety of emergency surgery among SSICH patients receiving LOAPT, thereby generating evidence to support future clinical management. Secondary Analysis Update: The present update describes an interim secondary analysis of the ongoing CRISIH registry based on patients enrolled during the initial five-year period from November 2019 to December 2024. This analysis focuses on postoperative disorders of consciousness after surgery for spontaneous intracerebral hemorrhage, with consciousness status assessed at 30, 90, 180, and 365 days after surgery using the Coma Recovery Scale-Revised. This interim secondary analysis does not alter the ongoing registry design, recruitment status, or originally registered primary outcome.
Eligibility 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.
Contact & Investigator
Shuo Wang
STUDY CHAIR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05975398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Spontaneous Intracranial Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05975398 currently recruiting?
Yes, NCT05975398 is actively recruiting participants. Contact the research team at captain9858@126.com for enrollment information.
Where is the NCT05975398 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05975398 clinical trial?
NCT05975398 is sponsored by Beijing Tiantan Hospital. The principal investigator is Shuo Wang at Beijing Tiantan Hospital. The trial plans to enroll 2,000 participants.