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
Sponsor:
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
  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 April 17, 2014