Perioperative Anticoagulant Use for Surgery Evaluation Study

NCT02228798 | Completed DMC

• 2 other identifiers: CIHR-PAUSE-2014CIHR313156 HSFG-14-0006163
• Study Type: observational
• Target: 3,135
• Locations: 5 countries
• Sites: 21

Brief Summary

The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to establish a safe, standardized protocol for the perioperative management of patients with atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.

Conditions

Atrial Fibrillation

Keywords

anticoagulant; atrial fibrillation; surgery; oral anticoagulant; discontinue; DOAC; NOAC; blood thinner; interruption

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Major Bleeds

  The first primary outcome is Major Bleed:Bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular. Non-surgical bleeding causing a drop in hemoglobin greater than or equal to 20 g per L or leading to transfusion greater or equal to 2 units of blood within 24 hours.Surgical bleed that leads to intervention or interferes with mobilization or leads to delayed wound healing; or leads to deep wound infection. Surgical site bleeding that is unexpected and prolonged and or sufficiently large to cause hemodynamic instability associated with a drop in hemoglobin greater or equal to 20 g per L or transfusion of greater or equal to 2 units of blood within 24 hours. The second primary outcome is atrial thromboembolism (ATE), comprising: Ischemic stroke,Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ or transient ischemic attack.

  Within 30 days of surgery or procedure

• Number of participants with Atrial Thromboembolism

  The second primary outcome is atrial thromboembolism (ATE), comprising: * Ischemic stroke: any new focal neurologic deficit that persists for \>24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain. * Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging studies (e.g. CT angiography). * Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically less than 1 hour), that occurs with no evidence of acute infarction on CT or MRI of brain.

  Within 30 days of surgery or procedure

Secondary Outcomes (4)

• Number of participants with Minor bleeding

  30 days or less after surgery or porcedure

• Number of participants who die

  30 days or after surgery or procedure

• Number of participants that have a Venous Thromboembolism (VTE)

  30 days or less after surgery

• Number of participants who acquire Acute Coronary Syndrome

  30 days or less after surgery or procedure

Other Outcomes (6)

• Dilute TT test-Laboratory blood test of NOAC levels

  Day of Surgery

• Anti-Xa test for NOAC level

  Day of surgery

• INR Laboratory Test

  Day of surgery

Study Arms (3)

Rivaroxaban

Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure.

Dabigatran

Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure.

Apixaban

Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those patients who are currently taking dabigatran, rivaroxaban or apixaban for oral anticoagulation used for stroke prevention in atrial fibrillation, and who require its temporary interruption for a surgical or other procedure, will be recruited from 15 to 25 participating sites across Canada. The study plans to screen 4,114 patients over a 3 year period, with 80 per cent expected enrollment (3,291 patients) from 16 sites across Canada. Equal number of patients, per oral anticoagulant arm will be enrolled, with approximately 1,000 patients taking each DOAC.

You may qualify if:

• Age 18 years or older
• Receiving a DOAC (dabigatran or rivaroxaban or apixaban) for Atrial Fibrillation
• Ability to assess patient at lease one day prior to DOAC discontinuation

You may not qualify if:

• CrCl less than 30 mL per min for dabigatran- and rivaroxaban-treated patients ( less than 25 mL per min for apixaban-treated patients) as estimated by Cockroft-Gault formula
• Cognitive impairment or psychiatric illness that precludes collection of followup data
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (21)

Department of Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA

Aurora, Colorado, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Department of Cardiovascular Sciences, University of Leuven

Leuven, Belgium

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

QEII Hospital

Halifax, Nova Scotia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

North York General

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

University of Manitoba

Winnipeg, Ontario, Canada

Location

Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Montreal General Hospital

Montreal, Quebec, Canada

Location

Montreal Jewish General Hospital

Montreal, Quebec, Canada

Location

St. Mary's Hospital

Montreal, Quebec, Canada

Location

Department of Anesthesiology, University of Thessaly

Larissa, Greece

Location

Department of Vascular Medicine, Amsterdam Cardiovascular Sciences

Amsterdam, Netherlands

Location

Related Publications (1)

• Shaw JR, Li N, Vanassche T, Coppens M, Spyropoulos AC, Syed S, Radwi M, Duncan J, Schulman S, Douketis JD. Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure. Blood Adv. 2020 Aug 11;4(15):3520-3527. doi: 10.1182/bloodadvances.2020002335.

  PMID: 32756938 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (platelet deprived plasma) will be collected on day of surgery/procedure and measured by 'everyday' coagulation tests that are not DOAC-specific (e.g., activated partial thromboplastin time \[aPTT\]) and 'specialized' coagulation tests that are DOAC-specific (dilute thrombin time \[TT\] - HemoclotTM, and anti-factor Xa assays) to determine the effect of the pre-operative DOAC interruption protocol on the level of residual anticoagulation.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Douketis, MD

  McMaster University/St. Joseph's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. James Douketis-Principal Investigator

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 29, 2014
• Study Start: August 1, 2014
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

US (3); BE (1); GR (1); NL (1); CA (15)