Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT00851864
Collaborator
LEO Pharma (Industry)
13
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1
43
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Weight-Adjusted Dosing of Tinzaparin in Pregnancy
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Women requiring therapeutic anticoagulation, singleton pregnancy,<30weeks

Drug: Tinzaparin
LMWH (tinzaparin-Innohep, Leo Pharma A/S) 175 anti-factor Xa units per kilogram of body weight sub-cutaneously once daily. Treatment will be done for the duration of the pregnancy.
Other Names:
  • innohep
  • Outcome Measures

    Primary Outcome Measures

    1. Rate of anti-Xa levels falling outside the target range of 0.4-1.2IU/mL [anti-Xa level Day 1,28, then q4 weeks]

    Secondary Outcome Measures

    1. mean dosage requirement in each trimester [1 year]

    2. rate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Calgary Health Region Calgary Alberta Canada T2N 4N1

    Sponsors and Collaborators

    • University of Calgary
    • LEO Pharma

    Investigators

    • Principal Investigator: Paul Gibson, M.D. FRCPC, University of Calgary
    • Study Chair: Kendra Newell, M.D., University of Calgary
    • Study Chair: David Sam, M.D. FRCPC, University of Calgary

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Sue Ross, Adjunct Professor, University of Calgary
    ClinicalTrials.gov Identifier:
    NCT00851864
    Other Study ID Numbers:
    • 05161977
    First Posted:
    Feb 26, 2009
    Last Update Posted:
    Aug 15, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Dr. Sue Ross, Adjunct Professor, University of Calgary
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2013