Status:
WITHDRAWN
A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days
Lead Sponsor:
Ross Leighton
Collaborating Sponsors:
Nova Scotia Health Authority
Conditions:
Thromboembolism
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
Brief 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 d...
Detailed Description
We will enroll one hundred patients who are scheduled to have a total knee replacement. If you have signed the consent form for this study you will receive the standard of care treatment for blood clo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00868179
Start Date
April 1 2009
End Date
April 1 2012
Last Update
November 14 2022
Active Locations (1)
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1
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3h 1V7