Effect of Protocol-Based Antithrombotic Management on Surgery Outcomes
in Patients Taking Chronic Antithrombotic Drugs
Led by Peking University First Hospital · Updated on 2025-07-31
526
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Managing surgical patients who take antithrombotic medications is challenging because these drugs affect blood clotting, increasing bleeding risk, but stopping them may cause clot-related problems. This research evaluates whether following a protocol-based approach for managing antithrombotic therapy around the time of surgery can improve outcomes for patients who have been on long-term antithrombotic treatment. The study is interventional and pragmatic in design, aiming to assess the impact of such management on perioperative events.
Participants are assigned to one of two groups one group receives perioperative antithrombotic management based on the latest expert consensus guidelines published in 2020, while the other group receives routine care as usual. Both approaches involve managing antithrombotic drugs before, during, and after surgery, specifically in patients undergoing intra-abdominal surgeries including general and urologic operations.
During the study, researchers will monitor participants for up to 30 days after surgery to assess a combined outcome of major bleeding and serious cardiovascular or cerebrovascular events. They will also track other postoperative complications, length of hospital stay, total hospital expenses, and all-cause mortality within this period. Participants will have preoperative assessments and follow-up visits to gather this information and ensure safety throughout the study.
CONDITIONS
Brief Title
Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy
Research Team
H
Hong Zhang, MD
H
Huai-Jin Li, MD
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Patients with ongoing antithrombotic therapy for cardiovascular or cerebrovascular diseases for more than 2 weeks
Patients with one or more of the following: high-risk atrial fibrillation, artificial heart valve, recent venous thromboembolism, coronary heart disease with recent procedures, recent stroke or transient ischemic attack, or peripheral arterial disease
Patients scheduled for intra-abdominal surgery including general or urologic surgery
Patients who provide written informed consent
You will not qualify if you...
Refusal to participate in the study
Emergency surgery cases
Inability to complete preoperative assessment or follow-up
Other reasons deemed unsuitable by investigators or attending doctors
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 30 days after surgery
Participants receive perioperative antithrombotic therapy management according to either protocol-based or routine practice during the perioperative period.
Visits during hospital stay and up to 30 days post-surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prospective observational cohort study of the association between antiplatelet therapy, bleeding and thrombosis in patients with coronary stents undergoing noncardiac surgery.
Perioperative cardiovascular complications versus perioperative bleeding in consecutive patients with known cardiac disease undergoing non-cardiac surgery. Focus on antithrombotic medication. The PRAGUE-14 registry.