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

Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thromboembolism; Hemodialysis

Intervention: Fragmin (dalteparin) (Drug); Innohep (tinzaparin) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Ottawa Hospital Research Institute

Official(s) and/or principal investigator(s):
Marc Rodger, MD, MSc, Principal Investigator, Affiliation: OHRI

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.

Clinical Details

Official title: Tinzaparin Versus Dalteparin for Perioperative Thromboembolic Prophylaxis in Patients With Dialysis Dependent Renal Disease- A Canadian Multicentre Trial

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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:

The frequency of surgery cancellation

Bleeding complications

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

St. Joseph's Healthcare, Hamilton, Ontario L8N4A6, Canada

The Ottawa Hospital, Ottawa, Ontario K1Y4E9, Canada

Additional Information

Starting date: October 2003
Last updated: September 8, 2014

Page last updated: August 23, 2015

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