Clinical trial NCT05975398: China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
Official title: China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Spontaneous Intracranial Hemorrhage
Long-term Antiplatelet Treatment
Emergency Surgery
Complications
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Shuyi Hospital
name: Beijing Anzhen Hospital
name: Guangzhou Red Cross Hospital
name: Beijing Pinggu District Hospital
name: Beijing Friendship Hospital
name: Wuxi No. 2 People's Hospital
name: Dezhou People's Hospital
name: Binzhou People's Hospital
First posted: 2023-08-03
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All severe spontaneous intracerebral hemorrhage (SSICH) patients except those not on long-term oral antiplatelet treatment (LOAPT) receiving conservative treatment.

Brief 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.


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.

Primary outcomes:
measure: Total mortality
timeFrame: From admission to 6 months after the occurrence primary hemorrhage
Secondary outcomes:
measure: Postoperative intracranial bleeding
timeFrame: Within one week after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang
role: STUDY_CHAIR
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