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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851864
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : August 15, 2013
LEO Pharma
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary

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
Venous Thromboembolism Drug: Tinzaparin 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Weight-Adjusted Dosing of Tinzaparin in Pregnancy
Study Start Date : October 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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 Name: innohep

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

Secondary Outcome Measures :
  1. mean dosage requirement in each trimester [ Time Frame: 1 year ]
  2. rate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851864

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Canada, Alberta
Calgary Health Region
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
LEO Pharma
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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

Publications of Results:
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Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary Identifier: NCT00851864     History of Changes
Other Study ID Numbers: 05161977
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by Dr. Sue Ross, University of Calgary:
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action