Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing
Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism
Intervention: Tinzaparin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Calgary Official(s) and/or principal investigator(s): Paul Gibson, M.D. FRCPC, Principal Investigator, Affiliation: University of Calgary Kendra Newell, M.D., Study Chair, Affiliation: University of Calgary David Sam, M.D. FRCPC, Study Chair, Affiliation: University of Calgary
Summary
The purpose of this study is to evaluate the safety and efficacy of therapeutic
anticoagulation with tinzaparin during pregnancy via weight-based dosing.
Clinical Details
Official title: Weight-Adjusted Dosing of Tinzaparin in Pregnancy
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Rate of anti-Xa levels falling outside the target range of 0.4-1.2IU/mL
Secondary outcome: mean dosage requirement in each trimesterrate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology
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 recent anticoagulation guidelines from American College of Chest
Physicians (ACCP) suggest that heparin levels (anti-Factor-Xa activity levels) may be done
periodically through pregnancy to determine the need to adjust the dose of LMWH as pregnancy
progresses. This monitoring is widely practiced. There is no clear consensus in the
literature, however, with some experts suggesting that initial and subsequent dosing may be
done based on weight alone (as is done in the non-pregnant population). Given the multiple
physiologic changes which occur to drug metabolism during pregnancy, this bears further
evaluation. To date, there is very limited data on weight-adjusted dosing of LMWH in
pregnancy. This study is therefore designed to determine if dosing of tinzaparin during
pregnancy based on weight, with periodic weight-based adjustments, will result in adequate
therapeutic anticoagulation.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Calgary Health Region, Calgary, Alberta T2N 4N1, Canada
Additional Information
Starting date: October 2007
Last updated: August 14, 2013
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