Status:
COMPLETED
A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
LEO Pharma
Conditions:
Thromboembolism
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to better understand if either dalteparin or tinzaparin is a better drug to use in dialysis patients on blood thinners who are at high risk of developing blood clots and n...
Detailed Description
A prospective multicenter randomised trial involving 60 consecutive eligible and consenting patients from teaching hospitals in Canada. Patients will be randomised to either tinzaparin or dalteparin t...
Eligibility Criteria
Inclusion
- Informed consent
- Patients aged \>= 18 with end stage renal disease requiring chronic hemodialysis (HD) three times a week and clinically stable on HD for 4 weeks (x 4 wks)
- Patients requiring active oral anticoagulation for prosthetic heart valves, recent deep vein thrombosis \>= 1 month, or patients with atrial fibrillation and a major risk factor (previous transient ischemic attack \[TIA\] or stroke, high blood pressure, diabetes, aged \>= 75, moderate/severe left ventricle dysfunction) who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
Exclusion
- Evidence of active bleeding prior to stopping warfarin
- Hemoglobin \<= 90 or platelet count \<= 100x10\^9/L
- Uncontrolled hypertension or stroke within 6 months of study commencement
- Spinal or neurosurgery
- Eye surgery (excluding cataract surgery)
- Life expectancy less than 3 months
- Patients requiring cardiac surgery
- Presence of active duodenal ulcer
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00260988
Start Date
October 1 2003
End Date
November 1 2008
Last Update
September 10 2014
Active Locations (2)
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1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N4A6
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9