A Phase 2/3 interventional study of Fragmin (dalteparin) and Innohep (tinzaparin) in Thromboembolism and Hemodialysis, sponsored by Ottawa Hospital Research Institute. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-10.
Sponsored by Ottawa Hospital Research Institute · Phase 2/3, Interventional, and Prevention
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 need surgery.
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 to investigate the pharmacokinetics of both low molecular weight heparins (LMWH) perioperatively in a special population, namely end stage renal disease (ESRD) dialysis patients.
To date although there exists evidence to suggest tinzaparin may be safe in patients on hemodialysis, LMWHs as a group have not been investigated in the perioperative setting in these patients. This protocol has been developed so that the pharmacokinetic behaviour of tinzaparin and dalteparin can be compared but also so that the duration off warfarin is minimised. Therapeutic doses of LMWH are administered pre-procedure during as much time of the period as possible that oral anticoagulation is sub-therapeutic.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 29 is below the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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Exclusion Criteria:
Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery
Drug: Fragmin (dalteparin)
Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery
Drug: Innohep (tinzaparin)
200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
Primary outcome will be the comparison of the pharmacokinetic profiles of dalteparin and tinzaparin in patients on hemodialysis in the setting of perioperative anticoagulation for thromboembolic prophylaxis. Specifically pre-dialysis anti-Xa levels post
Anti-Xa levels were drawn pre-dialysis (at a timepoint that was within 20-24hrs post- LMWH dose) and post- dialysis
Time frame: Pre-dialysis following the third dose of LMWH
The frequency of surgery cancellation
We will collect data on reasons why surgeries were cancelled in this patient population
Time frame: Cumulatively collected at end of study
Bleeding complications
Time frame: Any reported and elicited bleeding event will be captured throughout the study period
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute