Using a protocol to manage antithrombotic medicines around surgery
Effect of Protocol-based Management on Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy: a Pragmatic Interventional Study
This study will test whether following a specific protocol for managing blood thinners before, during, and after surgery reduces bleeding and clotting complications in people on long-term antithrombotic therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 526 (estimated) |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04852406 on ClinicalTrials.gov |
What this trial studies
This pragmatic interventional trial randomizes patients on chronic antithrombotic therapy to protocol-based perioperative management versus routine care to compare a composite of perioperative outcomes. Eligible patients are those taking antiplatelet and/or anticoagulant drugs for cardiovascular or cerebrovascular disease and meeting high-risk criteria who are scheduled for surgery. The protocol is based on multidisciplinary guideline and expert-consensus recommendations and standardizes timing of drug withholding, bridging, and resumption. Outcomes include perioperative bleeding, thrombotic events, and other perioperative complications collected at a single tertiary hospital site.
Who should consider this trial
Good fit: Ideal candidates are adults on chronic antithrombotic therapy (antiplatelet and/or anticoagulant for >2 weeks) with high thrombotic risk (for example high CHA2DS2-VASc, recent valve replacement, recent VTE, recent stent/CABG, or recent stroke) who are planning elective surgery.
Not a fit: Patients not taking chronic antithrombotic medications, those with low thrombotic risk, or those needing urgent or emergency surgery are unlikely to benefit from this perioperative protocol.
Why it matters
Potential benefit: If successful, the protocol could reduce bleeding and thrombotic complications and make perioperative anticoagulant care safer and more consistent for patients.
How similar studies have performed: Guidelines and expert consensus support protocolized antithrombotic management, but randomized and pragmatic data on clinical outcome benefits are limited and evidence is scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hong Zhang — Peking University First Hospital
- Study coordinator: Hong Zhang, MD
- Email: zhanghong40@hotmail.com
- Phone: 86 10 83572784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.