China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Launched by BEIJING TIANTAN HOSPITAL · Aug 2, 2023

Keywords

ClinConnect Summary

The CRISIH trial is studying the effects and safety of emergency surgery in patients with severe spontaneous intracerebral hemorrhage (SSICH) who are on long-term antiplatelet treatment (LOAPT), which is a type of medication that helps prevent blood clots. The goal is to understand whether surgery can help these patients survive better compared to those who receive only conservative treatment, which means managing their condition without surgery. This research is taking place at several hospitals and involves about 450 patients, who will be monitored for up to six months after their bleeding event.

To be eligible for this trial, participants must be between 18 and 75 years old and have a serious brain bleed that meets specific criteria, such as having a certain amount of bleeding in the brain or a low level of consciousness. They also need to have family members who agree to participate. Those with certain pre-existing conditions, other types of brain injuries, or severe bleeding disorders will not be included. If you or a loved one is considering participation, you can expect close monitoring and support throughout the study, which aims to provide valuable insights for future treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) 18-75 years old;
• • (2) non-traumatic intracerebral hemorrhage;
• • (3) severe intracerebral hemorrhage, which was defined as patients with supratentorial bleeding volume \> 30 ml, infratentorial bleeding volume \> 10 ml, midline shift \> 1 cm, or large intraventricular hematoma;
• • (4) Glasgow coma score (GCS) \< 13;
• • (5) family members agree to provide an informed written consent.
• Exclusion Criteria:
• • (1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors, which were associated with hemorrhage;
• • (2) hemorrhagic transformation of cerebral infarction;
• • (3) hemorrhage caused by venous thrombosis;
• • (4) patients with severe coagulation disorder, e.g., hemophilia;
• • (5) patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on;
• • (6) patients receiving other anticoagulation medications (vitamin K antagonist and new oral anticoagulants);
• • (7) patients not on LOAPT who receive conservative treatment;
• • (8) the patients who died before or on arriving at the hospital and within a short period (6 h) after admission.