Status:
COMPLETED
Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
LEO Pharma
Conditions:
Venous Thromboembolism
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of therapeutic anticoagulation with tinzaparin during pregnancy via weight-based dosing.
Detailed Description
Physicians in the Calgary Health Region are using tinzaparin (predominantly) and other low molecular weight heparins (LMWHs) for the treatment venous thromboembolism (VTE) in pregnancy. The most recen...
Eligibility Criteria
Inclusion
- Singleton pregnancies in women over the age of 18 requiring anticoagulation for acute VTE (DVT/PE), or high-risk prophylaxis at a tinzaparin dose of 175 IU/kg.
- High-risk patients include those with multiple (two or more) episodes of VTE and/or women receiving long-term anticoagulants (e.g. single event with known thrombophilia; APLAs and history of venous thrombosis)
Exclusion
- Multiple gestation\\
- Prosthetic valves
- Active bleeding or other contraindication to anticoagulation therapy
- Allergy to heparin, bisulfites, or fish, history of HIT (heparin induced thrombocytopenia), severe hypertension (diastolic \>130)
- Severe hepatic or renal failure
- Patients over 100kg.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00851864
Start Date
October 1 2007
End Date
May 1 2011
Last Update
August 15 2013
Active Locations (1)
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1
Calgary Health Region
Calgary, Alberta, Canada, T2N 4N1