Clinical trial NCT04852406: Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy
Official title: Effect of Protocol-based Management on Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy: a Pragmatic Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antithrombotic Therapy
Perioperative Care
Perioperative Outcomes
Keywords: perioperative care
antithrombotic therapy
perioperative outcomes
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 526
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Incidence of other postoperative complications
timeFrame: Up to 30 days after surgery
measure: The length of hospital stay
timeFrame: Up to 30 days after surgery
measure: Total expenses during hospitalization
timeFrame: Up to 30 days after surgery
measure: All-cause mortality rate within 30 days after surgery
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Hong Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.