Clinical trial NCT00260988: A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery
Official title: Tinzaparin Versus Dalteparin for Perioperative Thromboembolic Prophylaxis in Patients With Dialysis Dependent Renal Disease- A Canadian Multicentre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Thromboembolism
Hemodialysis
Keywords: Prophylaxis
Thromboembolic disease
End stage renal disease
Hemodialysis
Pharmacokinetics
Low Molecular Weight Heparin
Innohep
Tinzaparin
Fragmin
Dalteparin
Anti Xa
INR
Oral anticoagulation
warfarin
Coumadin
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2005-12-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: 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
timeFrame: Pre-dialysis following the third dose of LMWH
Secondary outcomes:
measure: The frequency of surgery cancellation
timeFrame: Cumulatively collected at end of study
measure: Bleeding complications
timeFrame: Any reported and elicited bleeding event will be captured throughout the study period
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Marc Rodger, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: