Back to resultsA Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery
Primary Purpose
Thromboembolism, Hemodialysis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fragmin (dalteparin)
Innohep (tinzaparin)
Sponsored by
About this trial
This is an interventional prevention trial for Thromboembolism focused on measuring Prophylaxis, Thromboembolic disease, End stage renal disease, Hemodialysis, Pharmacokinetics, Low Molecular Weight Heparin, Innohep, Tinzaparin, Fragmin, Dalteparin, Anti Xa, INR, Oral anticoagulation, warfarin, Coumadin
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
Sites / Locations
- St. Joseph's Healthcare
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dalteparin
Tinzaparin
Arm Description
Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery
Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery
Outcomes
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
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
We will collect data on reasons why surgeries were cancelled in this patient population
Bleeding complications
Full Information
NCT ID
NCT00260988
First Posted
November 30, 2005
Last Updated
September 8, 2014
Sponsor
Ottawa Hospital Research Institute
Collaborators
LEO Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00260988
Brief Title
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
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalteparin
Arm Type
Active Comparator
Arm Description
Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery
Arm Title
Tinzaparin
Arm Type
Active Comparator
Arm Description
Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery
Intervention Type
Drug
Intervention Name(s)
Fragmin (dalteparin)
Intervention Description
200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
Intervention Type
Drug
Intervention Name(s)
Innohep (tinzaparin)
Intervention Description
175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
Primary Outcome Measure Information:
Title
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
Description
Anti-Xa levels were drawn pre-dialysis (at a timepoint that was within 20-24hrs post- LMWH dose) and post- dialysis
Time Frame
Pre-dialysis following the third dose of LMWH
Secondary Outcome Measure Information:
Title
The frequency of surgery cancellation
Description
We will collect data on reasons why surgeries were cancelled in this patient population
Time Frame
Cumulatively collected at end of study
Title
Bleeding complications
Time Frame
Any reported and elicited bleeding event will be captured throughout the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Rodger, MD, MSc
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
12. IPD Sharing Statement
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A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery
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