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Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

Primary Purpose

Bradycardia, Tachycardia, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continue warfarin through the procedure
Hold warfarin
Warfarin held with heparin transition.
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradycardia focused on measuring bleeding, anticoagulation, pacemaker, implantable cardioverter-defibrillator, patients undergoing implantation of a pacemaker or defibrillator (ICD)"

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • scheduled for clinically indicated permanent pacemaker or implantable cardioverter-defibrillator
  • currently on chronic warfarin therapy

Exclusion Criteria:

  • unwilling to participate in trial

Sites / Locations

  • Johns Hopkins Bayview Medical Center
  • Howard County General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.

Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).

High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure.

High risk patients randomized to holding coumadin for 4-5 days and using "bridging" anticoagulation with heparin while the coumadin is held.

Outcomes

Primary Outcome Measures

Bleeding Complication
Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.
Thromboembolic Events
Anticoagulant Related Complications
Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia

Secondary Outcome Measures

Full Information

First Posted
July 21, 2008
Last Updated
July 31, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00721136
Brief Title
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Official Title
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation. This may require inpatient hospitalization several days prior to and after the procedure, potentially increasing medical costs and patient inconvenience. Patients undergoing such a process are initiated on heparin while their INRs drift to normal levels. Immediately prior to surgery, heparin is discontinued and restarted several hours after the procedure. Unfortunately, this process has resulted in a high incidence of surgical wound hematomas and other bleeding complications often requiring longer periods of discontinued anticoagulation or repeat surgical exploration. Previous investigators have tried to reduce the incidence of wound hematomas by prolonging the time from surgical wound closure to the reinitiation of heparin. A small randomized trial demonstrated that there was no significant difference in the incidence of wound hematomas whether heparin was started 6 hours or 24 hours after surgery (J Am Coll Cardiology 2000;35:1915-8). This has led many investigators to perform pacemaker and ICD implantation without reversal of warfarin therapy. A recent retrospective observational study demonstrated that the incidence of wound hematomas in patients with an INR of 2.6 was no different than patients with an INR of 1.5 (PACE 2004;27:358-60). Furthermore, a more recent, larger retrospective observational study reported in abstract form at the recent Heart Rhythm Society Annual 2007 Scientific Meeting demonstrated that not only is performing pacemaker and ICD implantations safe without reversing warfarin anticoagulation, but the incidence of wound hematomas is significantly smaller as compared to the strategy of reversing warfarin and initiating periprocedural heparin. Given these findings, the hypothesis of this randomized study is that pacemaker and ICD implantation while fully anticoagulated on warfarin therapy is safe. Findings from this study will have significant implications on the clinical practice of pacemaker or ICD implantation in this patient population given that no randomized study on this subject has been performed to date.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Tachycardia, Atrial Fibrillation, Valvular Heart Disease
Keywords
bleeding, anticoagulation, pacemaker, implantable cardioverter-defibrillator, patients undergoing implantation of a pacemaker or defibrillator (ICD)"

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
Arm Title
3
Arm Type
Experimental
Arm Description
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure.
Arm Title
4
Arm Type
Active Comparator
Arm Description
High risk patients randomized to holding coumadin for 4-5 days and using "bridging" anticoagulation with heparin while the coumadin is held.
Intervention Type
Drug
Intervention Name(s)
continue warfarin through the procedure
Intervention Description
The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
Intervention Type
Drug
Intervention Name(s)
Hold warfarin
Intervention Description
For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
Intervention Type
Drug
Intervention Name(s)
Warfarin held with heparin transition.
Intervention Description
For high risk patients, warfarin is held for 4-5 days prior to the procedure and heparin is given to provide anticoagulation while the INR is subtherapeutic.
Primary Outcome Measure Information:
Title
Bleeding Complication
Description
Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.
Time Frame
30 days
Title
Thromboembolic Events
Time Frame
30 days
Title
Anticoagulant Related Complications
Description
Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: scheduled for clinically indicated permanent pacemaker or implantable cardioverter-defibrillator currently on chronic warfarin therapy Exclusion Criteria: unwilling to participate in trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Cheng, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Howard County General Hospital
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

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