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Recruiting NCT04852406

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

No phase Interventional Antithrombotic Therapy Perioperative Care Perioperative Outcomes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Protocol-based management of perioperative antithrombotic therapy, Routine management of perioperative antithrombotic therapy.
Who it may be relevant to
Registry conditions: Antithrombotic Therapy, Perioperative Care, Perioperative Outcomes. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.
  • Drug Routine management of perioperative antithrombotic therapy
    Perioperative antithrombotic therapy is managed according to current routine practice.

Primary outcome measures

  • Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events [Time frame: Up to 30 days after surgery]
Secondary outcome measures (4)
  • Incidence of other postoperative complications [Time frame: Up to 30 days after surgery]
  • The length of hospital stay [Time frame: Up to 30 days after surgery]
  • Total expenses during hospitalization [Time frame: Up to 30 days after surgery]
  • All-cause mortality rate within 30 days after surgery [Time frame: Up to 30 days after 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 PMID 30686302

Identifiers

NCT: NCT04852406 · 2020-432

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗