American College of Surgeons' Guidelines for the Perioperative Management of Antithrombotic Medication.
Melissa A Hornor, Therese M Duane, Anne P Ehlers...
https://pubmed.ncbi.nlm.nih.gov/30145286Actively Recruiting
Phase Not Applicable
All Genders
ID04852406
Effect of Protocol-based Management on Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy: a Pragmatic Interventional Study
Led by Peking University First Hospital · Updated on 2025-07-31
526
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
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
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
H
Hong Zhang, MD
H
Huai-Jin Li, MD
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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