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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 trimester

rate 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

Page last updated: August 23, 2015

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