China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

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

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

Interventions

PROCEDURE

Emergency neurosurgery

Surgical evacuation for intracerebral hemorrhage

PROCEDURE

Conservative treatment

Standard treatment for intracerebral hemorrhage

Sponsors & Collaborators

• Beijing Chao Yang Hospital

  collaborator OTHER

• Beijing Shuyi Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Guangzhou Red Cross Hospital

  collaborator OTHER

• Beijing Pinggu District Hospital

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Wuxi No. 2 People's Hospital

  collaborator OTHER

• Dezhou People's Hospital

  collaborator OTHER

• Binzhou People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Anxi County Hospital

  collaborator UNKNOWN

• Datong People's Hospital

  collaborator UNKNOWN

• Shijiazhuang Third Hospital

  collaborator UNKNOWN

• Qingyuan People's Hospital

  collaborator OTHER

• Jingzhou Central Hospital

  collaborator OTHER

• Jiuquan City People's Hospital

  collaborator UNKNOWN

• Zhoukou People's Hospital

  collaborator UNKNOWN

• Jincheng People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Xinyu People's Hospital

  collaborator UNKNOWN

• Beijing Tiantan Hospital

  lead OTHER

Principal Investigators

• Shuo Wang · Beijing Tiantan Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2029-12-30

Completion

2030-12-31

Countries

• China

Study Locations