China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

NCT05975398 | Recruiting

• 1 other identifier: KY2019-096-02-1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-term Antiplatelet Treatment; Emergency Surgery; Complications; Disorders of Consciousness; Severe Spontaneous Intracranial Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Total mortality

  From admission to 6 months after the occurrence primary hemorrhage

Secondary Outcomes (2)

• Postoperative intracranial bleeding

  Within one week after surgery

• Postoperative disorders of consciousness

  30, 90, 180, and 365 days after surgery

Interventions

Emergency neurosurgery PROCEDURE

Surgical evacuation for intracerebral hemorrhage

Conservative treatment PROCEDURE

Standard treatment for intracerebral hemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with spontaneous, nontraumatic intracerebral hemorrhage enrolled in the ongoing CRISIH registry at participating clinical centers in China, receiving surgical or conservative management according to clinical indications and routine clinical practice. Severe spontaneous intracerebral hemorrhage (SSICH) is defined as supratentorial hematoma volume \>30 mL, infratentorial hematoma volume \>10 mL, midline shift \>1 cm, large intraventricular hematoma, or Glasgow Coma Scale (GCS) score \<13.

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Shuyi Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Guangzhou Red Cross Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Wuxi No. 2 People's Hospital: collaborator
• Dezhou People's Hospital: collaborator
• Binzhou People's Hospital: collaborator
• Anxi County Hospital: collaborator
• Datong People's Hospital: collaborator
• Shijiazhuang Third Hospital: collaborator
• Qingyuan People's Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Zhoukou People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Xinyu People's Hospital: collaborator
• Jiuquan City People's Hospital: collaborator
• Jincheng People's Hospital: collaborator
• Beijing Pinggu District Hospital: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Consciousness Disorders

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shuo Wang

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Shuo Wang

CONTACT

+86 13801180330; captain9858@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 3, 2023
• Study Start: November 1, 2019
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)