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

Purpose

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.

Condition	Intervention	Phase
Thromboembolism Hemodialysis	Drug: Fragmin (dalteparin) Drug: Innohep (tinzaparin)	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Tinzaparin Versus Dalteparin for Perioperative Thromboembolic Prophylaxis in Patients With Dialysis Dependent Renal Disease- A Canadian Multicentre Trial

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Dialysis

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:

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 [ Time Frame: Pre-dialysis following the third dose of LMWH ] [ Designated as safety issue: Yes ]
Anti-Xa levels were drawn pre-dialysis (at a timepoint that was within 20-24hrs post- LMWH dose) and post- dialysis

Secondary Outcome Measures:

The frequency of surgery cancellation [ Time Frame: Cumulatively collected at end of study ] [ Designated as safety issue: No ]
We will collect data on reasons why surgeries were cancelled in this patient population
Bleeding complications [ Time Frame: Any reported and elicited bleeding event will be captured throughout the study period ] [ Designated as safety issue: Yes ]


Enrollment:	29
Study Start Date:	October 2003
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Dalteparin Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery	Drug: Fragmin (dalteparin) 200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
Active Comparator: Tinzaparin Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery	Drug: Innohep (tinzaparin) 175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the 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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260988

Locations


Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N4A6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9

Sponsors and Collaborators

Ottawa Hospital Research Institute

LEO Pharma

Investigators


Principal Investigator:	Marc Rodger, MD, MSc	OHRI

More Information


Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00260988 History of Changes
Other Study ID Numbers:	2003391-01H
Study First Received:	November 30, 2005
Last Updated:	September 8, 2014
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:


Prophylaxis Thromboembolic disease End stage renal disease Hemodialysis Pharmacokinetics Low Molecular Weight Heparin Innohep Tinzaparin	Fragmin Dalteparin Anti Xa INR Oral anticoagulation warfarin Coumadin

Additional relevant MeSH terms:


Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Dalteparin Heparin, Low-Molecular-Weight	Tinzaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016