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

Not Applicable

• Conditions: Antithrombotic Therapy; Perioperative Care; Perioperative Outcomes
• Interventions: Drug: Routine management of perioperative antithrombotic therapy; Drug: Protocol-based management of perioperative antithrombotic therapy

• Registration Number: NCT04852406
• Lead Sponsor: Peking University First Hospital

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 antithrombotic therapy before surgery.

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 disturbance induced by these medications may increase the risk of bleeding, whereas withholding these medications may increase the risk of thrombotic events. It is a dilemma when managing these patients.

The guidelines and expert consensus published by multiple disciplinary teams constitute the perioperative antithrombotic management protocols. However, the effects of perioperative antithrombotic management guided by these guidelines or expert consensus are seldom reported. The investigators hypothesize that a protocol-based perioperative antithrombotic management can benefit patients with chronic antithrombotic therapy before surgery.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study Start: 2021-04-21
• Study First Posted: 2021-04-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-10
• Last Update Posted: 2021-07-13
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 526

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Routine management of perioperative antithrombotic therapy	Participants in this group receive routine management of perioperative antithrombotic therapy.
Intervention group	Protocol-based management of perioperative antithrombotic therapy	Participants in this group receive protocol-based management of perioperative antithrombotic therapy.

Primary Outcome Measures

Name	Time	Method
Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events	Up to 30 days after surgery	Major bleeding indicates bleeding of type 2 or higher on the BARC (Bleeding Academic Research Consortium) criteria. Major adverse cardiovascular or cerebrovascular events indicate acute coronary syndrome, acute myocardium infarction, ischemic stroke/transient ischemic attack, systemic arterial embolism, pulmonary embolism, or all-cause death.

Secondary Outcome Measures

Name	Time	Method
Incidence of other postoperative complications	Up to 30 days after surgery	Other postoperative complications indicate any newly occurred medical events that are harmful to patients' recovery and required therapeutic intervention, except major bleeding and major adverse cardiovascular or cerebrovascular events.
Total expenses during hospitalization	Up to 30 days after surgery	Total expenses during hospitalization
All-cause mortality rate within 30 days after surgery	Up to 30 days after surgery	All-cause mortality rate within 30 days after surgery
The length of hospital stay	Up to 30 days after surgery	The length of hospital stay from admission to discharge

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China