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NCT Number: NCT04852406

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Hong Zhang, MD

CONTACT

[email protected]

86 10 83572784

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protocol-based management of perioperative antithrombotic therapy

Drug

Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.

Other names: Protocol-based management

Routine management of perioperative antithrombotic therapy

Drug

Perioperative antithrombotic therapy is managed according to current routine practice.

Other names: Routine management

Primary outcomes

  1. Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events

    Time frame: Up to 30 days after surgery

    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.

Secondary outcomes

  1. Incidence of other postoperative complications

    Time frame: Up to 30 days after surgery

    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.

  2. The length of hospital stay

    Time frame: Up to 30 days after surgery

    The length of hospital stay from admission to discharge

  3. Total expenses during hospitalization

    Time frame: Up to 30 days after surgery

    Total expenses during hospitalization

  4. All-cause mortality rate within 30 days after surgery

    Time frame: Up to 30 days after surgery

    All-cause mortality rate within 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Zhang, MD

CONTACT

[email protected]

86 10 83572784

Huai-Jin Li, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 21, 2021
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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