Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00721136 · ClinicalTrials.gov registry record · NA
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 104
- Enrollment target
NCT00721136: Completed NA study, sponsored by Johns Hopkins University.
NCT00721136 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 104 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00721136, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 104 participants
- Enrollment target
Study 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 antic
Interventions
- DRUG continue warfarin through the procedure
- DRUG Hold warfarin
- DRUG Warfarin held with heparin transition.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00721136
The ClinicalTrials.gov registry entry for NCT00721136 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which continue warfarin through the procedure is the first listed.
NCT00721136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00721136 about?
NCT00721136 is a clinical study titled "Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation". 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 m...
What is the current status of trial NCT00721136?
This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2007-09. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00721136?
The interventions under investigation include: continue warfarin through the procedure (DRUG), Hold warfarin (DRUG), Warfarin held with heparin transition. (DRUG).
Who is sponsoring clinical trial NCT00721136?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.