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Sponsors and Collaborators: |
Hamilton Health Sciences St. Joseph's Healthcare |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00253396 |
The purpose of this study is to determine which short-acting blood thinner (low-molecular-weight heparin [Enoxaparin] or unfractionated heparin) is associated with less discomfort and bruising when given as a subcutaneous (under the skin) injection before and after a planned surgery or procedure in patients who temporarily stop warfarin.
Condition | Intervention | Phase |
---|---|---|
Bruises |
Drug: Unfractionated heparin Drug: Enoxaparin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | THE PRISM Study-Low-Molecular-Weight Heparin Versus Unfractionated Heparin for Perioperative Bridging Anticoagulation: the Patient Preference for Self-Injection Study and Related Measurements |
Estimated Enrollment: | 100 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2008 |
Increasing Patient Comfort and Compliance: The Bridging Anticoagulation Clinic strives to provide the highest quality of care to patients who require temporary interruption of warfarin therapy. An important component of optimizing patient care is minimizing patient discomfort with perioperative administration of short-acting anticoagulants (LWMH or UFH) used for bridging therapy, which, in turn, may optimize patient compliance with this treatment. This issue is especially relevant for patients who are receiving out-of-hospital treatment with LMWH or UFH because about 85% of such patients will be taught to self-administer this medication. This study seeks to determine if there is less discomfort and bruising associated with self-injection of LMWH than with UFH.
Minimizing Injection Site Bruising: No studies, to our knowledge, have assessed the characteristics or clinical importance of bruising in patients receiving subcutaneous LMWH or UFH. Thus, there is no evidence to support any association between bruising and discomfort. To bridge this gap in knowledge, we will document each injection site during the course of the study and measure the amount of bruising observed using a standardized photographic methodology. Injection site bruising has the potential to cause medical problems if an injection site hematoma develops, which can become infected or can cause long-term discomfort.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karen Woods, RN | 905-522-1155 ext 3754 | kwoods@mcmaster.ca |
Contact: James D Douketis, MD | 905-522-1155 ext 6178 | jdouket@mcmaster.ca |
Canada, Ontario | |
St. Joseph's Healthcare | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Contact: Karen Woods, RN 905-522-1155 ext 3754 kwoods@mcmaster.ca | |
Contact: James Douketis, MD 905-522-1155 ext 6178 jdouket@mcmaster.ca | |
Principal Investigator: Karen Woods, RN |
Principal Investigator: | Co-Investigators Dr. James Douketis and Karen Woods RN | McMaster University |
Study ID Numbers: | 05-2482 |
Study First Received: | November 14, 2005 |
Last Updated: | July 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00253396 |
Health Authority: | Canada: Health Canada |
warfarin clinical trial pain measurement |
heparin heparin, low-molecular-weight Anticoagulants |
Body Weight Contusions Heparin, Low-Molecular-Weight Pain |
Warfarin Heparin Enoxaparin Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |