RecruitingNot ApplicableNCT04852406

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

Effect of Protocol-based Management on Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy: a Pragmatic Interventional Study


Sponsor

Peking University First Hospital

Enrollment

526 participants

Start Date

Apr 21, 2021

Study Type

INTERVENTIONAL

Conditions

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 antithrombotic therapy before surgery.


Eligibility

Inclusion Criteria4

  • \. Patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks.
  • \. 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.
  • \. Patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery).
  • \. Patients who sign written informed consents.

Exclusion Criteria4

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

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Interventions

DRUGProtocol-based management of perioperative antithrombotic therapy

Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.

DRUGRoutine management of perioperative antithrombotic therapy

Perioperative antithrombotic therapy is managed according to current routine practice.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT04852406


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