A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Thromboembolism Hemodialysis | Drug: Fragmin (dalteparin) Drug: Innohep (tinzaparin) | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Tinzaparin Versus Dalteparin for Perioperative Thromboembolic Prophylaxis in Patients With Dialysis Dependent Renal Disease- A Canadian Multicentre Trial |
- 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 [ Time Frame: 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
- The frequency of surgery cancellation [ Time Frame: Cumulatively collected at end of study ]We will collect data on reasons why surgeries were cancelled in this patient population
- Bleeding complications [ Time Frame: Any reported and elicited bleeding event will be captured throughout the study period ]
| Enrollment: | 29 |
| Study Start Date: | October 2003 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dalteparin
Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery
|
Drug: Fragmin (dalteparin)
200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
|
|
Active Comparator: Tinzaparin
Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery
|
Drug: Innohep (tinzaparin)
175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the 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.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260988
| Canada, Ontario | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N4A6 | |
| The Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1Y4E9 | |
| Principal Investigator: | Marc Rodger, MD, MSc | OHRI |
More Information
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00260988 History of Changes |
| Other Study ID Numbers: |
2003391-01H |
| First Submitted: | November 30, 2005 |
| First Posted: | December 2, 2005 |
| Last Update Posted: | September 10, 2014 |
| Last Verified: | July 2009 |
Keywords provided by Ottawa Hospital Research Institute:
|
Prophylaxis Thromboembolic disease End stage renal disease Hemodialysis Pharmacokinetics Low Molecular Weight Heparin Innohep Tinzaparin |
Fragmin Dalteparin Anti Xa INR Oral anticoagulation warfarin Coumadin |
Additional relevant MeSH terms:
|
Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Dalteparin Heparin, Low-Molecular-Weight |
Tinzaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |