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Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00786474
First received: November 5, 2008
Last updated: October 13, 2014
Last verified: October 2014

November 5, 2008
October 13, 2014
July 2009
January 2015   (final data collection date for primary outcome measure)
  • Arterial thromboembolic events, defined as an ischemic stroke, transient ischemic attack, or systemic embolism [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
  • Major bleeding, symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
  • Arterial thromboembolic events, defined as an ischemic stroke, transient ischemic attack, or systemic embolis [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
  • Major bleeding, symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00786474 on ClinicalTrials.gov Archive Site
  • Acute myocardial infarction, deep vein thrombosis, or pulmonary embolism [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
  • Minor bleeding [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
  • Acute myocardial infarction (with ST- and non-ST-elevation), deep vein thrombosis, or pulmonary embolism [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
  • Minor bleeding [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)
Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery

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.

Approximately 2 million people in North America take the anticoagulant warfarin to prevent stroke, heart attack, and other events related to blood clots. Warfarin needs to be stopped before a person undergoes surgery or certain procedures because it can cause dangerous amounts of bleeding during and after surgery. Some doctors give a low molecular weight heparin (LMWH) to patients during the 2-week period when participants are without the effects of warfarin. The LMWH has the same effect as warfarin, but it acts and then leaves the system more quickly than warfarin. However, the LMWH is expensive, may increase the risk of bleeding, and has not been proven effective. This study will determine the safety and efficacy of an LMWH in adults with atrial fibrillation who stop warfarin in preparation for surgery.

Participation in this study will last between 36 and 67 days. Participation will involve nine points of contact with researchers, at least two of which will be in-person visits at the research clinic. The others will be conducted by phone. All points of contact will include assessments on possible bleeding and any new symptoms. The first two of these points of contact, will take place at the signing of the informed consent, which will involve a screening of medical records and random assignment of participants to receive either the LMWH dalteparin or placebo. Participants will self-administer a subcutaneous injection of their assigned treatment twice a day for 3 days before the surgery or procedure and for 6 days after. During the course of the study, when participants visit their primary physicians for regularly scheduled appointments, it will be recommended that they undergo two international normalized ratio (INR) tests of blood clotting ability between day 2 and 10 after the surgery or procedure. The remaining seven points of contact will occur sometime between the day before surgery and 37 days after surgery. One of the in-person visits will occur within the first week after surgery and will include assessments on possible bleeding, any new symptoms, and INR results.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Arterial Thromboembolic Events
  • Atrial Fibrillation
  • Drug: Placebo
    Normal saline solution, dosage determined by weight, self-administered by patient twice a day
  • Drug: Dalteparin
    Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
    Other Name: Fragmin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Dalteparin
    Intervention: Drug: Dalteparin
Assaad B, Sesi VK, Figari R, Schultz L, Thummala N, Rehman M, Chandok A, Silverman A, Silver B. Antithrombotic management of stroke patients before colonoscopy. J Stroke Cerebrovasc Dis. 2013 Aug;22(6):733-6. doi: 10.1016/j.jstrokecerebrovasdis.2011.12.006. Epub 2012 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2526
March 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Wanda G. Parker, RN, MSN 919-668-8589 parke010@dcri.duke.edu
United States
 
NCT00786474
Pro00017344, 1U01HL086755-01A1, 1U01HL087229
Yes
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Thomas L. Ortel, MD Duke University
Principal Investigator: Victor Hasselblad, PhD Duke Clinical Research Institute
Duke University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP