Patients Preference With Self-Injection: The PRISM Study

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: St. Joseph's Health Care London
• Treatments: Calcium heparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

1. Patient is receiving warfarin therapy with a target international normalized ratio (INR) of 2.0-3.5

2. Patient requires temporary interruption of warfarin because of elective surgery or procedure.

Exclusion Criteria:

1. History of allergy to heparin, including heparin-induced thrombocytopenia (HIT)

2. Bridging anticoagulation with low molecular weight heparin (LMWH) or unfractionated heparin (UFH) not indicated

3. Impaired cognitive function or language barrier

4. Creatinine clearance < 30 ml/min

5. Patient declines consent

6. Patient is < 18 years of age.

7. Patient is not willing and able to self inject.

8. Patient has significant visual or hand motor impairment