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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04820972
Enrollment
269
Registered
2021-03-29
Start date
2021-05-01
Completion date
2023-05-01
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Intracerebral Hemorrhage

Keywords

antiplatelet treatment, spontaneous intracerebral hemorrhage, early-start, neurosurgery

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.

Interventions

using antiplatelet agents in 3 days after surgery

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
rate of intracranial hemorrhage7 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events7 days after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026