Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage

Study Overview
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Brief Summary
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This study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. In addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.An independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.To evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.

Official Title
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Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage

Conditions
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Spontaneous Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: Antiplatelet Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years old. nontraumatic spontaneous intracerebral hemorrhage. postoperative patients with high risk of MACCPE:(1)previous history of cerebral infarction or TIA. (2)previous history of coronary heart disease or myocardial infarction.(3) use ASCVD Risk Estimator Plus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction,10 years risk>10% is defined as a high risk of cardiovascular ischemic events(4)The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities.Score>2 is defined as a high risk of venous thrombosis. patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration. patients who signed informed consent. no history of allergy to salicylic acid preparation. patients who complete the preintervention assessment and meet the fellow criteria:(1)postoperative head CT showed no new infarction or hemorrhage(2)postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischemia or myocardial infarction. Exclusion Criteria: there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions. ischemic stroke with hemorrhagic conversion. secondary bleeding due to venous embolism. the malignant tumor is expected to have a survival of no more than 3 months. take antithrombotic agents((Vitamin K antagonists (warfarin) new anticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents. previous history of thrombocytopenia or coagulation disorders. previous history of atrial fibrillation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-STAR group<br> | Drug: Antiplatelet Agents<br>* using antiplatelet agents in 3 days after surgery<br>|
| No Intervention: traditional group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of intracranial hemorrhage |  | 7 days after surgery | 
| rate of intracranial hemorrhage |  | 14 days after surgery | 
| rate of intracranial hemorrhage |  | 30 days after surgery | 
| rate of intracranial hemorrhage |  | 90 days after surgery | 
| rate of major adverse cardiac/cerebrovascular and peripheral vessel events |  | 7 days after surgery | 
| rate of major adverse cardiac/cerebrovascular and peripheral vessel events |  | 14 days after surgery | 
| rate of major adverse cardiac/cerebrovascular and peripheral vessel events |  | 30 days after surgery | 
| rate of major adverse cardiac/cerebrovascular and peripheral vessel events |  | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiplatelet treatment, spontaneous intracerebral hemorrhage, early-start, neurosurgery