Patients Preference With Self-Injection: The PRISM Study

Bruises Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruises

• NCT number: NCT00253396
• Study type: Interventional
• Source: McMaster University
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Completion date: January 2007