Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT04192552

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PAUSE Perioperative DOAC Management

ASRA Perioperative DOAC Management

Study Details

Brief summary:

The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC) and require an elective surgery/procedure. PAUSE did not address safe management of patients having a high-bleed-risk surgery/neuraxial anesthesia in whom there is concern about bleeding, especially neuraxial-related epidural hematomas that can lead to paralysis; such patients are often managed by the approach recommended by the American Society of Regional Anesthesia (ASRA). In PAUSE-2, investigators will test the hypothesis: (i) for patients having a high-bleed-risk surgery/neuraxial anesthesia, the simpler "PAUSE management" is as safe (non-inferior) to the more complex "ASRA management". PAUSE-2 will establish a standard for perioperative DOAC management in patients having high-bleed-risk surgery or neuraxial anesthesia.

To start, this will be a pilot study of a larger PAUSE-2-RCT. The investigators will be conducting this pilot study to assess the feasibility of the study at this smaller scale.

Conditions

Atrial Fibrillation

Study ID

NCT04192552

Start date

Jan 9, 2020

Status verified date

Jan, 2020

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (age ≥18 years) with AF/flutter who is receiving a DOAC: apixaban 2.5 mg or 5 mg BID; dabigatran 110 mg or 150 mg BID; or rivaroxaban 15 mg or 20 mg QD.
  • Undergoing an elective surgery/procedure associated with a high-bleed-risk or any surgery/procedure requiring neuraxial anesthesia (includes regional blocks)
  • Patient and their clinician are willing to adhere to DOAC interruption/continuation protocols.
  • Patient to resume DOAC after surgery/procedure (i.e., no intent to discontinue DOAC).

Exclusion Criteria:

  • Creatinine clearance (CrCl) <30 mL/min (dabigatran, rivaroxaban) and <25 mL/min (apixaban) based on the Cockroft-Gault equation, which is recommended for DOAC dosing.
  • Patient taking a DOAC that is infrequently used (i.e., edoxaban, <5% Canadian DOAC market share in 2018) or is not available for clinical use in Canada or Europe (i.e., betrixaban).
  • Patient taking a DOAC for a non-AF clinical indication (excluded to maintain study population homogeneity).
  • Cognitive impairment or psychiatric illness that precludes collection of follow-up data.
  • Inability or unwillingness to provide informed consent.
  • Previous participation in PAUSE-2.

Study Design

Enrollment

201 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Apixaban

Patients currently taking apixaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia.

active comparator: Dabigatran

Patients currently taking dabigatran that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia.

active comparator: Rivaroxaban

Patients currently taking rivaroxaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia.

Interventions

PAUSE Perioperative DOAC Management

Apixaban \& Rivaroxaban: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure.

Dabigatran (see below):

CrCl ≥50: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure.

CrCl <50: Hold DOAC for 4 days before procedure. Re-start DOAC 2+ days post-procedure.

ASRA Perioperative DOAC Management

Apixaban \& Rivaroxaban: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure.

Dabigatran (see below):

CrCl >80: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure.

CrCl 50-80: Hold DOAC for 4 days before procedure. Re-start DOAC 1+ days post-procedure.

CrCl 30-49: Hold DOAC for 5 days before procedure. Re-start DOAC 1+ days post-procedure.

\*Low-dose heparin bridging can be used if at high A-TE risk

Primary outcome measure

  • Number of patients who had a major bleed [ Time Frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date ]
  • Number of patients who had an Arterial Thromboembolism (ATE) [ Time Frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date ]

Central Contacts and Locations

Central contacts

James D Douketis, MD

905-522-1155jdouket@mcmaster.ca

Joanne Duncan, MSc

duncanj@mcmaster.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada

Contacts

Michelle Zondag

905-527-4322zondag@hhsc.ca

More Information

Sponsor

McMaster University

Last update posted

Jan 22, 2020

Last verified

Jan, 2020

Keywords

  • anticoagulant
  • atrial fibrillation
  • surgery
  • oral anticoagulant
  • high risk
  • blood thinner
  • DOAC
  • interruption
  • discontinue
  • elective
  • perioperative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2020-01-22.