Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy
NCT ID: NCT04852406
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
526 participants
INTERVENTIONAL
2021-04-21
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention group
Participants in this group receive protocol-based management of perioperative antithrombotic therapy.
Protocol-based management of perioperative antithrombotic therapy
Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.
Control group
Participants in this group receive routine management of perioperative antithrombotic therapy.
Routine management of perioperative antithrombotic therapy
Perioperative antithrombotic therapy is managed according to current routine practice.
Interventions
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Protocol-based management of perioperative antithrombotic therapy
Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.
Routine management of perioperative antithrombotic therapy
Perioperative antithrombotic therapy is managed according to current routine practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor
Principal Investigators
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Hong Zhang
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-432
Identifier Type: -
Identifier Source: org_study_id
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