RECRUITING

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: A Randomized Control Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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: A Randomized Control Trial

Quick Facts

Study Start:2025-04-01
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06957366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults, age 18 years of age or greater, with AF/flutter (permanent, persistent or paroxysmal) or VTE (leg deep vein thrombosis or pulmonary embolism) that require a full (therapeutic)-dose DOAC regimen, appropriate for age and renal function, comprising one of (a) apixaban 2.5 mg or 5 mg bid; (b) dabigatran 110 mg or 150 mg bid; (c) edoxaban 30 mg or 60 mg daily; or (d) rivaroxaban 15 mg or 20 mg daily
  2. * High-risk patient having an elective high-bleed-risk surgery or any elective surgery with neuraxial anesthesia (epidural, spinal, regional) or any deep nerve root block.
  1. * Indication for anticoagulation is unusual site thrombosis (e.g. splanchnic, cerebral, sinus, arm)
  2. * Receiving a low-dose DOAC regimen used for secondary VTE prevention (e.g. rivaroxaban 10 mg daily, apixaban 2.5 mg bid) or another low-dose DOAC regimen (e.g. rivaroxaban 2.5 mg bid)
  3. * CrCL\<25mL/min (if on apixaban, edoxaban, rivaroxaban) or \<30 mL/min (if on dabigatran)
  4. * cognitive impairment or psychiatric illness that precludes reliable contact during follow up.
  5. * Unable or unwilling to provide consent
  6. * Previous participation in PAUSE 2

Contacts and Locations

Study Contact

James Douketis, MD
CONTACT
905-522-1155
jdouket@mcmaster.ca
Melanie St John
CONTACT
stjohm1@mcmaster.ca

Principal Investigator

James Douketis, MD
PRINCIPAL_INVESTIGATOR
McMaster University/St. Joseph's Healthcare
Joseph Shaw, MD
PRINCIPAL_INVESTIGATOR
The Ottawa Hospital

Study Locations (Sites)

Hartford Health Care
Hartford, Connecticut, 06106
United States
North Shore University Health
Evanston, Illinois, 60201
United States
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
United States
Henry Ford Health Care
Detroit, Michigan, 48202
United States
Northwell Health System
New York, New York, 10305
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: McMaster University

  • James Douketis, MD, PRINCIPAL_INVESTIGATOR, McMaster University/St. Joseph's Healthcare
  • Joseph Shaw, MD, PRINCIPAL_INVESTIGATOR, The Ottawa Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • anticoagulation
  • atrial Fibrillation
  • Surgery
  • Oral Anticoagulant
  • Blood thinner
  • DOAC
  • VTE
  • Interruption
  • PAUSE

Additional Relevant MeSH Terms

  • Atrial Fibrillation (AF)
  • VTE