NCT05975398

China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Emergency neurosurgery	Surgical evacuation for intracerebral hemorrhage
PROCEDURE	Conservative treatment	Standard treatment for intracerebral hemorrhage

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-08-03
• Last updated: 2023-11-28

Locations

1 site across 1 country: China