Status:
COMPLETED
Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
The Second Affiliated Hospital of Kunming Medical University
First Affiliated Hospital of Fujian Medical University
Conditions:
Spontaneous Intracerebral Hemorrhage
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 metho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT04820972
Start Date
May 1 2021
End Date
May 1 2023
Last Update
April 3 2025
Active Locations (1)
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1
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China