Hemodialysis, Thromboembolism
Conditions
Keywords
Prophylaxis, Thromboembolic disease, End stage renal disease, Hemodialysis, Pharmacokinetics, Low Molecular Weight Heparin, Innohep, Tinzaparin, Fragmin, Dalteparin, Anti Xa, INR, Oral anticoagulation, warfarin, Coumadin
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 need surgery.
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 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.
Interventions
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
Sponsors
LEO Pharma
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre-dialysis following the third dose of LMWH | Anti-Xa levels were drawn pre-dialysis (at a timepoint that was within 20-24hrs post- LMWH dose) and post- dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of surgery cancellation | Cumulatively collected at end of study | We will collect data on reasons why surgeries were cancelled in this patient population |
| Bleeding complications | Any reported and elicited bleeding event will be captured throughout the study period | — |
Countries
Canada
Outcome results
None listed