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

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Antiplatelet Agents

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JUN WU, MD; Phone Number: +8613426322945; Email: wujunslf@126.com
• Study Contact Backup: Name: Shuo Wang, MD; Phone Number: 13801180330; Email: captain9858@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Capital Medical University Affiliated Beijing Tiantan Hospital
      • Contact: JUN WU, MD; Phone Number: +8613426322945; Email: wujunslf@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Friendship Hospital; RenJi Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital of Fujian Medical University; Beijing Chao Yang Hospital; Fujian Medical University Union Hospital; Sichuan Academy of Medical Sciences; First Affiliated Hospital of Harbin Medical University; The Second Affiliated Hospital of Kunming Medical University; Chongqing General Hospital; Binzhou Medical University; The Second Xiangya Hospital of Central South Medical University; Gangzhou Red Cross Hospital ，Jinan University; Shanxi Provincial People Hospital
• Investigators: Principal Investigator: Shuo Wang, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: neurosurgery; spontaneous intracerebral hemorrhage; antiplatelet treatment; early-start
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Platelet Aggregation Inhibitors
• Other Study ID Numbers: HX-A-007（2021）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No