A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Ottawa Hospital Research Institute.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Ottawa Hospital Research Institute
Collaborator:
LEO Pharma
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00260988
First received: November 30, 2005
Last updated: July 8, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thromboembolism Hemodialysis |
Drug: Fragmin (dalteparin) Drug: Innohep (tinzaparin) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Ottawa Hospital Research Institute:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- The frequency of surgery cancellation
- Pre-procedure anti-Xa levels
- Bleeding complications
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Dalteparin |
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 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260988
Locations
| Canada, Ontario | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N4A6 | |
| The Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1Y4E9 | |
Sponsors and Collaborators
Ottawa Hospital Research Institute
LEO Pharma
Investigators
| Principal Investigator: | Marc Rodger, MD, MSc | OHRI |
More Information
No publications provided
| Responsible Party: | Marc Rodger, Ottawa Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00260988 History of Changes |
| Other Study ID Numbers: | 2003391-01H |
| Study First Received: | November 30, 2005 |
| Last Updated: | July 8, 2009 |
| Health Authority: | Canada: Health Canada |
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 Thrombosis Heparin, Low-Molecular-Weight Dalteparin Tinzaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013