Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPeking University First Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Protocol-based management of perioperative antithrombotic therapy
DrugPerioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.
Routine management of perioperative antithrombotic therapy
DrugPerioperative antithrombotic therapy is managed according to current routine practice.
Treatment groups
526 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 30 days after surgerySecondary outcomes
1
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.
Time frame
Up to 30 days after surgery2
The length of hospital stay
The length of hospital stay from admission to discharge
Time frame
Up to 30 days after surgery3
Total expenses during hospitalization
Total expenses during hospitalization
Time frame
Up to 30 days after surgery4
All-cause mortality rate within 30 days after surgery
All-cause mortality rate within 30 days after surgery
Time frame
Up to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov