China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Summary

Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT.

Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSICH patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage.

Study Design: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established.

Objective: In this study, investigators will estimate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.

Conditions

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

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

• Beijing Tiantan Hospital

  lead OTHER

Principal Investigators

• Shuo Wang · Beijing Tiantan Hospital

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• China

Study Locations