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Perioperative Anticoagulant Use for Surgery Evaluation Study Part 2 Pilot

NCT04192552 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2020-01-22

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • James D Douketis, MD · McMaster University/St. Joseph's Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192552 on ClinicalTrials.gov