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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thromboembolism Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dalteparin

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

Group Type ACTIVE_COMPARATOR

Fragmin (dalteparin)

Intervention Type DRUG

200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Tinzaparin

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

Group Type ACTIVE_COMPARATOR

Innohep (tinzaparin)

Intervention Type DRUG

175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Interventions

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Fragmin (dalteparin)

200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Intervention Type DRUG

Innohep (tinzaparin)

175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No