Perioperative Anticoagulant Use for Surgery Evaluation Study (PAUSE)

McMaster University

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT02228798

CIHR-PAUSE-2014

CIHR313156 HSFG-14-0006163 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The primary aim is to demonstrate that a standardized but patient-focused protocol for the perioperative management of each DOAC is safe, with acceptably low rates of perioperative major bleeding (MB) and arterial thromboembolism (ATE). The perioperative protocol is adjusted based on patient renal function and surgery/procedure-related bleed risk, to optimize patient safety, and does not involve heparin bridging anticoagulation.

The secondary aim of the PAUSE Study is to determine the effect of the pre-operative DOAC interruption protocol on the level of residual anticoagulation, when 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).

Approximately 3,300 patients from 15 to 25 centres over a 3.5 year period will be recruited across Canada for the PAUSE Study.

Patients with Atrial Fibrillation and are currently taking dabigatran, rivaroxaban and apixaban (DOACs) and require elective surgery/procedure will follow a standardized management perioperative protocol for discontinuation of their DOAC prior to surgery. Patients will be discontinuing the DOAC they are currently receiving from 1 to 4 days prior to surgery or procedure, depending on bleed risk, type of DOAC, and creatinine clearance rate.

A blood sample will be taken on the day of the surgery or procedure for measurement of laboratory outcomes (residual level of anticoagulant on day of surgery).

Patients will be followed up weekly up to a month for primary outcome assessments.

Enrollment: 3,135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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
2. Cognitive impairment or psychiatric illness that precludes collection of followup data
3. Inability or unwillingness to provide informed consent

Trial design

3,135 participants in 3 patient groups

Rivaroxaban

Description:

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

Dabigatran

Description:

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

Apixaban

Description:

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