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Arterial Thromboembolic EventsPhase 3NCT00786474

Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)

A Phase 3 study testing Dalteparin in people with Arterial Thromboembolic Events and Atrial Fibrillation, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Dalteparin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,884 participants
Where
1 siteUnited States
Study dates
Jul 2009to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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)

Who cannot join

  • 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
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  • 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
  • More than one surgery planned during the trial period
  • Prior participation in this trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Clinical Research Institute

    Durham, North Carolina, 27715

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Placebo, Dalteparin
Keywords
Bridging Anticoagulation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • DalteparinDrug

    Also called Fragmin

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

Study groups in NCT00786474
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
DalteparinExperimentalNot described
Receives: Drug: Dalteparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (2)

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

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

  2. Number of Participants With Minor Bleeding

    Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2008 (estimated)
  2. Study startJul 2009
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,884 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00786474
Sponsor's protocol ID
Pro00017344
Other IDs
1U01HL086755-01A1, 1U01HL087229
Status last verified
Jan 2016
First submitted
5 Nov 2008
Last updated
7 Mar 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27280017

  • 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.

    PubMed 26095867

  • 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.

    PubMed 22244711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dalteparin in people with Arterial Thromboembolic Events and Atrial Fibrillation, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Arterial Thromboembolic Events (time frame: from subject signing of the consent until completed the study (Day -30 to Day +37)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00786474, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.

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