China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

July 8, 2026 updated by: Wang Shuo, Beijing Tiantan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Capital Medical University Affiliated Beijing Tiantan Hospital
        • Contact:
        • Principal Investigator:
          • Shuo Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total mortality
Time Frame: From admission to 6 months after the occurrence primary hemorrhage
From admission to 6 months after the occurrence primary hemorrhage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative intracranial bleeding
Time Frame: Within one week after surgery
Within one week after surgery
Postoperative disorders of consciousness
Time Frame: 30, 90, 180, and 365 days after surgery
Proportion of patients with postoperative disorders of consciousness after surgery for spontaneous intracerebral hemorrhage, assessed using the Coma Recovery Scale-Revised.
30, 90, 180, and 365 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

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

Investigators

  • Study Chair: Shuo Wang, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2019-096-02-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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