Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment

Phase

N/A

Condition

Stroke

Hemorrhage

Adverse Effects, Drugs

Treatment

N/A

Clinical Study ID

NCT05766865

KY2019-096-02

Ages 18-75
All Genders

Study 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 SSIC H 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.

Results: 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.

Conclusions: In this study, we will investigate 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

Inclusion Criteria:

(1) 18-75 years old;
(2) non-traumatic intracerebral hemorrhage;
(3) severe intracerebral hemorrhage, which was defined as patients with supratentorialbleeding 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

Exclusion Criteria:

(1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascularmalformation, 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, hepaticinsufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on;
(6) patients receiving other anticoagulation medications (vitamin K antagonist and neworal 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 shortperiod (6 h) after admission.

Study Design

July 10, 2019

November 30, 2022

Connect with a study center

Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing
China
Site Not Available

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