Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)
Condition: Arterial Thromboembolic Events; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Thromboembolism
Intervention: Placebo; Dalteparin
Intervention description: Normal saline solution, dosage determined by weight, self-administered by patient twice a day; Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1884.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bridging Anticoagulation

Summary:

      Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk
      of a stroke or heart attack. When people undergo surgery or certain procedures, they must
      stop using warfarin to prevent too much bleeding during and after the surgery or procedure.
      Some doctors prescribe a different blood thinner, one that works more quickly and wears off
      more quickly, to bridge the gap between starting and stopping warfarin. However, this
      short-term treatment is expensive, may increase the risk of bleeding, and has not been proven
      effective. This study will determine whether a bridging blood thinner called dalteparin is
      helpful or harmful for people with atrial fibrillation who stop taking warfarin in
      preparation for surgery or a procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving warfarin therapy for at least 3 months, administered to achieve an
             international normalized ratio (INR) range of 2.0 to 3.0

          -  Requiring temporary interruption of warfarin for pre-specified elective procedure or
             surgery

          -  Presence of one of the following conditions:

               1. Chronic (permanent or paroxysmal) nonvalvular atrial fibrillation, confirmed by
                  at least one prior electrocardiography recording or pacemaker or acid citrate
                  dextrose (ACD) interrogation

               2. Chronic (permanent or paroxysmal) valvular atrial fibrillation with evidence of
                  mitral valvular heart disease, confirmed by the same criteria as nonvalvular
                  atrial fibrillation

          -  Presence of at least one of the following major stroke risk factors:

               1. Older than 75 years of age

               2. Hypertension

               3. Diabetes mellitus

               4. Congestive heart failure or left ventricular dysfunction

               5. Previous ischemic stroke, systemic embolism, or transient ischemic attack (TIA)

        Exclusion Criteria:

          -  Any mechanical prosthetic heart valve

          -  Stroke (ischemic or hemorrhagic), systemic embolism, or TIA within the past 12 weeks

          -  Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12
             weeks

          -  Major bleeding within the past 6 weeks

          -  Severe renal insufficiency, measured through a calculated creatinine clearance of less
             than 30 mL/min

          -  Thrombocytopenia

          -  Life expectancy less than 1 month

          -  Condition that impairs compliance with trial protocol, such as cognitive impairment,
             an uncontrolled psychiatric condition, or geographic inaccessibility

          -  Pregnancy

          -  Allergy to heparin or history of heparin-induced thrombocytopenia

          -  Having one of the following surgeries or procedures during warfarin interruption:

               1. Cardiac surgery, such as coronary artery bypass or heart valve replacement

               2. Neurosurgery that is intracranial or intraspinal, such as tumor resection or
                  aneurysm repair

               3. High-risk non-surgical procedures, such as brain biopsy

          -  Other surgical or non-surgical procedure that, at the discretion of the surgeon,
             precludes administration of therapeutic-dose low molecular weight heparin (LMWH) at
             any time in the post-procedure period

          -  More than one surgery planned during the trial period

          -  Prior participation in this trial