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

Last updated: September 8, 2014
Sponsor: Ottawa Hospital Research Institute
Overall Status: Completed

Phase

2/3

Condition

Thromboembolism

Hemodialysis

Treatment

N/A

Clinical Study ID

NCT00260988
2003391-01H
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, recentdeep vein thrombosis >= 1 month, or patients with atrial fibrillation and a major riskfactor (previous transient ischemic attack [TIA] or stroke, high blood pressure,diabetes, aged >= 75, moderate/severe left ventricle dysfunction) who require electivenon-cardiac surgery or an invasive procedure with reversal of their anticoagulanttherapy.

Exclusion

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

Study Design

Total Participants: 29
Study Start date:
October 01, 2003
Estimated Completion Date:
November 30, 2008

Study 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.

Connect with a study center

  • St. Joseph's Healthcare

    Hamilton, Ontario L8N4A6
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1Y4E9
    Canada

    Site Not Available

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