A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Thromboembolism; Hemodialysis	Drug: Fragmin (dalteparin); Drug: Innohep (tinzaparin)	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
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
Study Start Date :	October 2003
Actual Primary Completion Date :	November 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. Bleeding complications [ Time Frame: Any reported and elicited bleeding event will be captured throughout the study period ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00260988 History of Changes
Other Study ID Numbers:	2003391-01H
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