Clinical trial NCT04820972: Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
Official title: Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spontaneous Intracerebral Hemorrhage
Keywords: antiplatelet treatment
spontaneous intracerebral hemorrhage
early-start
neurosurgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Kunming Medical University
name: First Affiliated Hospital of Fujian Medical University
name: The Second Xiangya Hospital of Central South Medical University
name: First Affiliated Hospital of Harbin Medical University
name: Gangzhou Red Cross Hospital ，Jinan University
name: Beijing Chao Yang Hospital
name: RenJi Hospital
name: Sichuan Academy of Medical Sciences
name: Chongqing General Hospital
name: Binzhou Medical University
name: Fujian Medical University Union Hospital
name: Shanxi Provincial People Hospital
name: Beijing Friendship Hospital
name: Qilu Hospital of Shandong University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2021-03-29
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: rate of intracranial hemorrhage
timeFrame: 7 days after surgery
measure: rate of intracranial hemorrhage
timeFrame: 14 days after surgery
measure: rate of intracranial hemorrhage
timeFrame: 30 days after surgery
measure: rate of intracranial hemorrhage
timeFrame: 90 days after surgery
measure: rate of major adverse cardiac/cerebrovascular and peripheral vessel events
timeFrame: 7 days after surgery
measure: rate of major adverse cardiac/cerebrovascular and peripheral vessel events
timeFrame: 14 days after surgery
measure: rate of major adverse cardiac/cerebrovascular and peripheral vessel events
timeFrame: 30 days after surgery
measure: rate of major adverse cardiac/cerebrovascular and peripheral vessel events
timeFrame: 90 days after surgery
Secondary outcomes:
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, MD
role: PRINCIPAL_INVESTIGATOR
References: