Hemodialysis Clinical Trial
Official title:
Tinzaparin Versus Dalteparin for Perioperative Thromboembolic Prophylaxis in Patients With Dialysis Dependent Renal Disease- A Canadian Multicentre Trial
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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