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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260988
• Other study ID #: 2003391-01H
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 30, 2005
• Last updated: September 8, 2014
• Start date: October 2003
• Est. completion date: November 2008

Study information

• Verified date: July 2009
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemodialysis
• Thromboembolism

Intervention

Drug:
• Fragmin (dalteparin)
200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
• Innohep (tinzaparin)
175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	LEO Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anti-Xa levels were drawn pre-dialysis (at a timepoint that was within 20-24hrs post- LMWH dose) and post- dialysis	Pre-dialysis following the third dose of LMWH	Yes
Secondary	The frequency of surgery cancellation	We will collect data on reasons why surgeries were cancelled in this patient population	Cumulatively collected at end of study	No
Secondary	Bleeding complications		Any reported and elicited bleeding event will be captured throughout the study period	Yes