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

Spontaneous Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820972
• Other study ID #: HX-A-007(2021)
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 2023

Study information

• Verified date: March 2021
• Source: Beijing Tiantan Hospital
• Contact: JUN WU, MD
• Phone: +8613426322945
• Email: wujunslf[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Spontaneous Intracerebral Hemorrhage

Intervention

Drug:
• Antiplatelet Agents
using antiplatelet agents in 3 days after surgery

Locations

Country	Name	City	State
China	Capital Medical University Affiliated Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (16)

Lead Sponsor

Collaborator

Beijing Tiantan Hospital

Beijing Chao Yang Hospital, Beijing Friendship Hospital, Binzhou Medical University, Chongqing General Hospital, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Harbin Medical University, Fujian Medical University Union Hospital, Gangzhou Red Cross Hospital ,Jinan University, Qilu Hospital of Shandong University, RenJi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanxi Provincial People Hospital, Sichuan Academy of Medical Sciences, The Second Affiliated Hospital of Kunming Medical University, The Second Xiangya Hospital of Central South Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of intracranial hemorrhage		7 days after surgery
Primary	rate of intracranial hemorrhage		14 days after surgery
Primary	rate of intracranial hemorrhage		30 days after surgery
Primary	rate of intracranial hemorrhage		90 days after surgery
Primary	rate of major adverse cardiac/cerebrovascular and peripheral vessel events		7 days after surgery
Primary	rate of major adverse cardiac/cerebrovascular and peripheral vessel events		14 days after surgery
Primary	rate of major adverse cardiac/cerebrovascular and peripheral vessel events		30 days after surgery
Primary	rate of major adverse cardiac/cerebrovascular and peripheral vessel events		90 days after surgery