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Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial

NCT00800137 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2018-08-15

No results posted yet for this study

Summary

Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high risk of blood clot formation. There is a substantial risk of bleeding in the pocket where the device is situated (pocket hematoma)related to bridging therapy. The purpose of this study is to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery, with the hypothesis being that the continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to the bridging with heparin group.

Conditions

  • Hematoma

Interventions

DRUG

low molecular weight heparin or unfractionated heparin

For elective patients with greater than 5 days pre-implant; discontinue oral anti-coagulation (coumadin) 5 days before the procedure. Full therapeutic doses of subcutaneous LMWH 3 days before the procedure. Patients with less than 5 days to implant can be given vitamin K (up to 2 mg) at the investigator discretion and start full therapeutic doses of either subcutaneous LMWH or IV Unfractionated Heparin (choice is at investigator's discretion) when INR is below the upper limit of the prescribed therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6. Last dose given in the morning(ie. \> 24 hours)of the day prior to the procedure. Oral anti-coagulation (coumadin) will be resumed on the evening of the procedure. Full dose LMWH or full dose IV heparin will be restarted 24 hours after surgery.

DRUG

Warfarin or coumadin

Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be \< 3.0

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • David Birnie, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Brazil
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800137 on ClinicalTrials.gov