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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00260988
Other study ID # 2003391-01H
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 30, 2005
Last updated September 8, 2014
Start date October 2003
Est. completion date November 2008

Study information

Verified date July 2009
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Fragmin (dalteparin)
200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
Innohep (tinzaparin)
175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario
Canada The Ottawa Hospital Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute LEO Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pre-dialysis following the third dose of LMWH Yes
Secondary The frequency of surgery cancellation We will collect data on reasons why surgeries were cancelled in this patient population Cumulatively collected at end of study No
Secondary Bleeding complications Any reported and elicited bleeding event will be captured throughout the study period Yes
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