A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days

• Status: Withdrawn
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently standard of care for preventing blood clots in total knee replacement patients is the drug Fragmin which is a daily injection for 10 days after surgery. Patients are in hospital for 3 to 5 days after total knee replacement surgery and patients are taught in hospital to do their injections.

The investigators would like to introduce the drug Pradax. Pradax is a Health Canada approved once a day, oral drug that may prevent blood clots in the patient's leg. In this study the patient will receive the standard of care injection drug Fragmin while in hospital but on discharge home the patient will take the oral drug Pradax daily (2 tablets 110mg) for 10 days.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Collaborator: Ross K Leighton MD FRCSC
• Treatments: Dabigatran

Criteria

Inclusion Criteria:

• Patients are eligible for the study if they are adult age, being greater than 18 years of age and less than 95 years of age. They must have the indications for a total knee replacement and have sufficiently passed the medically necessary tests by their surgeon to warrant total knee replacement.

Exclusion Criteria:

• Patients with active bleeding, or high risk of bleeding that contra-indicates the use of Pradax

• Renal or liver contra-indication necessitating adjustments of its dose.

• Clinically significant liver disease,

• Concomitant use of Proteus Ace inhibitors

• The use of the human immunitive deficiency virus

• The use of fibrinolynic agents

• Planned intermittent pneumatic compression or requirement of ongoing anticoagulation therapy

• Pregnancy

• Breast-feeding.