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

NCT04852406 | Recruiting DMC

• 1 other identifier: 2020-432
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antithrombotic Therapy; Perioperative Care; Perioperative Outcomes

Keywords

perioperative care; antithrombotic therapy; perioperative outcomes

Outcome Measures

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.

  Up to 30 days after surgery

Secondary Outcomes (4)

• Incidence of other postoperative complications

  Up to 30 days after surgery

• The length of hospital stay

  Up to 30 days after surgery

• Total expenses during hospitalization

  Up to 30 days after surgery

• All-cause mortality rate within 30 days after surgery

  Up to 30 days after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this group receive protocol-based management of perioperative antithrombotic therapy.

Drug: Protocol-based management of perioperative antithrombotic therapy

Control group

SHAM COMPARATOR

Participants in this group receive routine management of perioperative antithrombotic therapy.

Drug: Routine management of perioperative antithrombotic therapy

Interventions

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.

Also known as: Protocol-based management

Intervention group

Routine management of perioperative antithrombotic therapy DRUG

Perioperative antithrombotic therapy is managed according to current routine practice.

Also known as: Routine management

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks.
• \. 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.
• \. Patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery).
• \. Patients who sign written informed consents.

You may not qualify if:

• \. Refuse to participate.
• \. Emergency surgery.
• \. Unable to complete the preoperative assessment and follow-up plan.
• \. Other reasons that are considered unsuitable for study participation by the investigators or the attending doctors.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (11)

• Hornor MA, Duane TM, Ehlers AP, Jensen EH, Brown PS Jr, Pohl D, da Costa PM, Ko CY, Laronga C. American College of Surgeons' Guidelines for the Perioperative Management of Antithrombotic Medication. J Am Coll Surg. 2018 Nov;227(5):521-536.e1. doi: 10.1016/j.jamcollsurg.2018.08.183. Epub 2018 Aug 24. No abstract available.

  PMID: 30145286 BACKGROUND

• Dubois V, Dincq AS, Douxfils J, Ickx B, Samama CM, Dogne JM, Gourdin M, Chatelain B, Mullier F, Lessire S. Perioperative management of patients on direct oral anticoagulants. Thromb J. 2017 May 15;15:14. doi: 10.1186/s12959-017-0137-1. eCollection 2017.

  PMID: 28515674 BACKGROUND

• Torn M, Rosendaal FR. Oral anticoagulation in surgical procedures: risks and recommendations. Br J Haematol. 2003 Nov;123(4):676-82. doi: 10.1046/j.1365-2141.2003.04652.x.

  PMID: 14616972 BACKGROUND

• Oltmann SC, Alhefdhi AY, Rajaei MH, Schneider DF, Sippel RS, Chen H. Antiplatelet and Anticoagulant Medications Significantly Increase the Risk of Postoperative Hematoma: Review of over 4500 Thyroid and Parathyroid Procedures. Ann Surg Oncol. 2016 Sep;23(9):2874-82. doi: 10.1245/s10434-016-5241-0. Epub 2016 May 2.

  PMID: 27138383 BACKGROUND

• Yurttas T, Wanner PM, Filipovic M. Perioperative management of antithrombotic therapies. Curr Opin Anaesthesiol. 2017 Aug;30(4):466-473. doi: 10.1097/ACO.0000000000000481.

  PMID: 28509773 BACKGROUND

• Yong JW, Yang LX, Ohene BE, Zhou YJ, Wang ZJ. Periprocedural heparin bridging in patients receiving oral anticoagulation: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2017 Dec 13;17(1):295. doi: 10.1186/s12872-017-0719-7.

  PMID: 29237411 BACKGROUND

• Childers CP, Maggard-Gibbons M, Ulloa JG, MacQueen IT, Miake-Lye IM, Shanman R, Mak S, Beroes JM, Shekelle PG. Perioperative management of antiplatelet therapy in patients undergoing non-cardiac surgery following coronary stent placement: a systematic review. Syst Rev. 2018 Jan 10;7(1):4. doi: 10.1186/s13643-017-0635-z.

  PMID: 29321066 BACKGROUND

• Howell SJ, Hoeks SE, West RM, Wheatcroft SB, Hoeft A; OBTAIN Investigators of European Society of Anaesthesiology (ESA) Clinical Trial Network. Prospective observational cohort study of the association between antiplatelet therapy, bleeding and thrombosis in patients with coronary stents undergoing noncardiac surgery. Br J Anaesth. 2019 Feb;122(2):170-179. doi: 10.1016/j.bja.2018.09.029. Epub 2018 Dec 15.

  PMID: 30686302 BACKGROUND

• Widimsky P, Motovska Z, Havluj L, Ondrakova M, Bartoska R, Bittner L, Dusek L, Dzupa V, Knot J, Krbec M, Mencl L, Pachl J, Grill R, Haninec P, Waldauf P, Gurlich R. 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. Neth Heart J. 2014 Sep;22(9):372-9. doi: 10.1007/s12471-014-0575-3.

  PMID: 25120211 BACKGROUND

• Cao D, Mehran R, Dangas G, Baber U, Sartori S, Chandiramani R, Stefanini GG, Angiolillo DJ, Capodanno D, Urban P, Morice MC, Krucoff M, Goel R, Roumeliotis A, Sweeny J, Sharma SK, Kini A. Validation of the Academic Research Consortium High Bleeding Risk Definition in Contemporary PCI Patients. J Am Coll Cardiol. 2020 Jun 2;75(21):2711-2722. doi: 10.1016/j.jacc.2020.03.070.

  PMID: 32466887 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

Study Officials

• Hong Zhang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Zhang, MD

CONTACT

86 10 83572784; zhanghong40@hotmail.com

Huai-Jin Li, MD

CONTACT

crystal_35@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 21, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)