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

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Thromboembolism; Hemodialysis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00260988

2003391-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Dalteparin

Active Comparator group

Description:

Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery

Treatment:

Drug: Fragmin (dalteparin)

Tinzaparin

Active Comparator group

Description:

Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery

Treatment:

Drug: Innohep (tinzaparin)