Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)

NCT00786474 | Completed Phase 3 Results DMC

• 3 other identifiers: Pro000173441U01HL086755-01A11U01HL087229
• Study Type: interventional
• Target: 1,884
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arterial Thromboembolic Events; Atrial Fibrillation

Keywords

Bridging Anticoagulation

Outcome Measures

Primary Outcomes (2)

• Number of Arterial Thromboembolic Events

  The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated

  from subject signing of the consent until completed the study (Day -30 to Day +37)

• Major Bleeding

  Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death

  from subject signing of the consent until completed the study (Day -30 to Day +37)

Secondary Outcomes (2)

• Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism

  from subject signing of the consent until completed the study (Day -30 to Day +37)

• Number of Participants With Minor Bleeding

  from subject signing of the consent until completed the study (Day -30 to Day +37)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Dalteparin

EXPERIMENTAL

Drug: Dalteparin

Interventions

Placebo DRUG

Normal saline solution, dosage determined by weight, self-administered by patient twice a day

Placebo

Dalteparin DRUG

Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day

Also known as: Fragmin

Dalteparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Chronic (permanent or paroxysmal) nonvalvular atrial fibrillation, confirmed by at least one prior electrocardiography recording or pacemaker or acid citrate dextrose (ACD) interrogation
• 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:
• Older than 75 years of age
• Hypertension
• Diabetes mellitus
• Congestive heart failure or left ventricular dysfunction
• Previous ischemic stroke, systemic embolism, or transient ischemic attack (TIA)

You may not qualify if:

• 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:
• Cardiac surgery, such as coronary artery bypass or heart valve replacement
• Neurosurgery that is intracranial or intraspinal, such as tumor resection or aneurysm repair
• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27715, United States

Location

Related Publications (3)

• Wight JM, Columb MO. Perioperative bridging anticoagulation for atrial fibrillation-the first randomised controlled trial. Perioper Med (Lond). 2016 Jun 7;5:14. doi: 10.1186/s13741-016-0040-5. eCollection 2016.

  PMID: 27280017 DERIVED

• Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

  PMID: 26095867 DERIVED

• 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.

  PMID: 22244711 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Thomas Ortel, MD, PhD, Principal Investigator
• Organization: Duke University Medical Center

thomas.ortel@duke.edu

919-684-5350

Study Officials

• Thomas L. Ortel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Victor Hasselblad, PhD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: July 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-01

Locations

US (1)