920 Participants Needed

Perioperative Anticoagulant Management for Atrial Fibrillation

(PAUSE 2 RCT Trial)

Recruiting at 13 trial locations
MS
JD
Overseen ByJames Douketis, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
Must be taking: DOACs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it involves managing anticoagulant medications (blood thinners) for surgery. It's best to discuss with the trial team or your doctor.

What data supports the effectiveness of the drug ASRA Perioperative DOAC Management for atrial fibrillation?

The PAUSE study suggests that the perioperative management protocol for direct oral anticoagulants (DOACs) is safe for patients with atrial fibrillation, with low expected risks for major bleeding and arterial thromboembolism. This protocol is designed to be easily applied in clinical practice, providing a standardized yet patient-specific approach.12345

Is the perioperative anticoagulant management for atrial fibrillation generally safe for humans?

The PAUSE study found that the perioperative management of direct oral anticoagulants (DOACs) in patients with atrial fibrillation is generally safe, with low rates of major bleeding and thromboembolic events. The study showed that the standardized management protocol is effective in minimizing risks, with major bleeding rates of 3.02% for apixaban, 2.84% for dabigatran, and 4.16% for rivaroxaban.24678

How does the PAUSE perioperative DOAC management differ from other treatments for atrial fibrillation?

The PAUSE perioperative DOAC management is unique because it provides a standardized yet patient-specific protocol for managing direct oral anticoagulants (DOACs) around the time of surgery, considering factors like the type of DOAC, the patient's kidney function, and the bleeding risk of the surgery. This approach aims to safely balance the risk of bleeding and clotting, unlike traditional methods that may not be as tailored to individual patient needs.12469

What is the purpose of this trial?

PAUSE 2 study is a prospective, open-label, blinded-endpoint non-inferiority RCT of PAUSE vs. ASRA management in DOAC treated high risk patients with AF/VTE who need elective high bleed risk surgery/procedure and/or any procedure involving neuraxial anesthesia. The purpose of the PAUSE 2 study is to show that PAUSE management will be as safe (i.e., non-inferior) as ASRA management, with 95% of patients having low/undetectable pre-operative DOAC levels \<30 ng/mL in each group., at the time of surgery/neuraxial.

Research Team

JD

James Douketis, MD

Principal Investigator

McMaster University/St. Joseph's Healthcare

JS

Joseph Shaw, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for patients with atrial fibrillation or deep vein thrombosis who are on DOACs (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) and need elective surgery or a procedure that has a high risk of bleeding. Specific eligibility criteria were not provided.

Inclusion Criteria

I am an adult with AF/flutter or VTE and need a specific blood thinner dose.
I am a high-risk patient scheduled for surgery with a high risk of bleeding or requiring specific types of anesthesia.

Exclusion Criteria

Cognitive impairment or psychiatric illness that precludes reliable contact during follow up
My kidney function is low, but specific to my medication type.
Unable or unwilling to provide consent
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Management

Participants interrupt DOACs for 2 days before surgery without heparin bridging or DOAC level testing (PAUSE) or follow ASRA guidelines with 72-120 hours DOAC interruption and possible heparin bridging and DOAC level testing.

2-5 days

Surgery/Procedure

Participants undergo elective high bleed risk surgery or neuraxial procedure.

1 day

Post-operative Management

Participants resume DOACs 2 days after surgery without heparin bridging or DOAC level testing (PAUSE) or follow ASRA guidelines with possible heparin bridging and DOAC level testing.

2-5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for bleeding and thromboembolic events.

28 days

Treatment Details

Interventions

  • ASRA Perioperative DOAC Management
  • PAUSE Perioperative DOAC Management
Trial Overview The PAUSE-2 study compares two ways to manage blood thinners before surgery: the PAUSE method versus the ASRA guidelines. It's designed to see if the PAUSE approach is just as safe in ensuring low levels of blood thinners at surgery time.
Participant Groups
4Treatment groups
Active Control
Group I: ApixabanActive Control2 Interventions
Patients currently taking Apixaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
Group II: DabigatranActive Control2 Interventions
Patients currently taking Dabigatran that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
Group III: RivaroxabanActive Control2 Interventions
Patients currently taking Rivaroxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
Group IV: EdoxabanActive Control2 Interventions
Patients currently taking Edoxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

References

Coagulation assays and direct oral anticoagulant levels among patients having an elective surgery or procedure. [2023]
The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study for Patients on a Direct Oral Anticoagulant Who Need an Elective Surgery or Procedure: Design and Rationale. [2021]
Management of DOAC in Patients Undergoing Planned Surgery or Invasive Procedure: Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the Surveillance of the Antithrombotic Therapies (FCSA) Position Paper. [2022]
The perioperative management of new direct oral anticoagulants: a question without answers. [2022]
Peri-procedural management of dabigatran and rivaroxaban: Duration of anticoagulant discontinuation and drug concentrations. [2015]
Predictors of Bleeding in the Perioperative Anticoagulant Use for Surgery Evaluation Study. [2021]
Effect of Direct Oral Anticoagulant, Patient, and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation Study. [2020]
Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure. [2021]
Perioperative management of patients with atrial fibrillation receiving anticoagulant therapy. [2020]
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