Anticoagulant Therapy During Pacemaker Implantation

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

There are no established guidelines regarding interruption of warfarin anticoagulant therapy prior to surgical implantation of cardiac pacemakers. Continuing the anticoagulant could potentially result in increased bleeding complications from the implantation surgery, whereas discontinuing the anticoagulant could predispose the patient to blood clots and strokes. In this study we intend to randomly assign warfarin-treated patients either into interrupted or continued warfarin therapy prior to pacemaker implantation with the purpose of establishing the rate of complication in these groups. Our hypothesis is that a cardiac pacing device can be safely implanted without discontinuation of the anticoagulant therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turku
• Collaborators: Oulu University Hospital; Satakunta Central Hospital; Tampere University Hospital
• Treatments: Anticoagulants; Aspirin; Warfarin

Criteria

Inclusion Criteria:

• all patients admitted for implantation of a first permanent cardiac pacing device are eligible

Exclusion Criteria:

• known coagulation disorder or bleeding diathesis

• contraindications for pacing device implantation

• mechanical prosthetic heart valve

• other absolute contraindication to interrupt warfarin

• INR (international normalized ratio) above 3.0 2 days prior to implantation

• significant anemia (hemoglobin less than 100 g/L)

• warfarin interrupted before randomization and INR subtherapeutic (below 2.0)

• not to be randomized to venography: contraindications to radiographic contrast dye