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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Antithrombotic Therapy, Perioperative Care, Perioperative Outcomes

Intervention / Treatment
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* Drug: Protocol-based management of perioperative antithrombotic therapy
* Drug: Routine management of perioperative antithrombotic therapy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants in this group receive protocol-based management of perioperative antithrombotic therapy. | Drug: Protocol-based management of perioperative antithrombotic therapy<br>* Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.<br>* Other names: Protocol-based management;|
| Sham Comparator: Control group<br>Participants in this group receive routine management of perioperative antithrombotic therapy. | Drug: Routine management of perioperative antithrombotic therapy<br>* Perioperative antithrombotic therapy is managed according to current routine practice.<br>* Other names: Routine management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events | 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. | Up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of other postoperative complications | 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. | Up to 30 days after surgery | 
| The length of hospital stay | The length of hospital stay from admission to discharge | Up to 30 days after surgery | 
| Total expenses during hospitalization | Total expenses during hospitalization | Up to 30 days after surgery | 
| All-cause mortality rate within 30 days after surgery | All-cause mortality rate within 30 days after surgery | Up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative care, antithrombotic therapy, perioperative outcomes