China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Recruiting now

Conditions studied: Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment, Emergency Surgery, Complications, Disorders of Consciousness

In brief

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.

Key facts

Study ID: NCT05975398
Run by: Beijing Tiantan Hospital
People needed: 2000
Starts: 2019-11-01
Expected to finish: 2030-12-31
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 years or older.
Spontaneous, nontraumatic intracerebral hemorrhage.
Treatment with surgical or conservative management according to clinical indications and routine clinical practice.
Written informed consent provided by the patient or legally authorized representative/family member.

You may not qualify if…

Patients had cerebrovascular diseases associated with hemorrhage, such as intracranial aneurysm, cerebrovascular malformation, or intracranial tumors.
Hemorrhagic transformation of cerebral infarction.
Hemorrhage caused by cerebral venous thrombosis.
Patients with severe coagulation disorder, such as hemophilia.
Patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, or related conditions.
Patients receiving other anticoagulation medications, including vitamin K antagonists or novel oral anticoagulants.
Patients who died before arrival at the hospital, on arrival at the hospital, or within a short period (6 hours) after admission.

Where it is running

Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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