Status:

RECRUITING

Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy

Lead Sponsor:

Peking University First Hospital

Conditions:

Antithrombotic Therapy

Perioperative Care

Eligibility:

All Genders

Phase:

NA

Brief Summary

The purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic ...

Detailed Description

Aging population and chronic medical disease make the management of surgical patients more complex. About one tenth of patients scheduled for surgery are taking antithrombotic medications. Coagulation...

Eligibility Criteria

Inclusion

  • 1\. Patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks.
  • 2\. Patients who have one or more of the following situations: (1) non-valvular atrial fibrillation with a CHA2DS2-VASc score \>4; (2) post-artificial valve replacement (including mitral valve, ball-cage valve or tilting disc aortic valve); (3) venous thromboembolism occurred within 1 year, or venous thromboembolism with other high-risk factors which require long-term anticoagulation treatment; (4) coronary heart disease with coronary stent implantation, thrombolytic therapy or other coronary procedures within 2 years, or who had undergone coronary artery bypass grafting within 1 year, or who experienced myocardial infarction or acute coronary syndrome within 1 year; (5) a history of stroke/transient ischemic accident within 1 year, or a history of cervical or intracranial revascularization treatment within 1 year; (6) peripheral arterial disease.
  • 3\. Patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery).
  • 4\. Patients who sign written informed consents.

Exclusion

  • 1\. Refuse to participate.
  • 2\. Emergency surgery.
  • 3\. Unable to complete the preoperative assessment and follow-up plan.
  • 4\. Other reasons that are considered unsuitable for study participation by the investigators or the attending doctors.

Key Trial Info

Start Date :

April 21 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

526 Patients enrolled

Trial Details

Trial ID

NCT04852406

Start Date

April 21 2021

End Date

January 1 2026

Last Update

July 31 2025

Active Locations (1)

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1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034