Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
McMaster University
Study ID
NCT06957366
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)
  • VTE

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PAUSE Perioperative DOAC Management — OTHER
    PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing.
  • ASRA Perioperative DOAC Management — OTHER
    ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
920 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Apixaban
    Patients currently taking Apixaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
  • Active Comparator: Dabigatran
    Patients currently taking Dabigatran that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
  • Active Comparator: Rivaroxaban
    Patients currently taking Rivaroxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
  • Active Comparator: Edoxaban
    Patients currently taking Edoxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Primary Outcome Measure

Proportion of patients randomized to each study arm with a residual pre-operative DOAC level < 30 ng/mL [ Time Frame: Day 1 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Hartford Health CareHartfordConnecticut06106
Mandeep Kumar, MD (PRINCIPAL_INVESTIGATOR)
North Shore University HealthEvanstonIllinois60201
Alfonso Tafur, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Woman's HospitalBostonMassachusetts02115
Jean Connors, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health CareDetroitMichigan48202
Scott Kaatz, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health SystemNew YorkNew York10305
Alex Spyropoulos, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Geno Merli, MD (PRINCIPAL_INVESTIGATOR)

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Hartford Health Care· Hartford, CTNorth Shore University Health· Evanston, ILBrigham and Woman's Hospital· Boston, MAHenry Ford Health Care· Detroit, MINorthwell Health System· New York, NYThomas Jefferson University Hospital· Philadelphia, PA

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