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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851864
First Posted: February 26, 2009
Last Update Posted: August 15, 2013
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.
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
  Purpose
The purpose of this study is to evaluate the safety and efficacy of therapeutic anticoagulation with tinzaparin during pregnancy via weight-based dosing.

Condition Intervention Phase
Venous Thromboembolism Drug: Tinzaparin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Weight-Adjusted Dosing of Tinzaparin in Pregnancy

Resource links provided by NLM:


Further study details as provided by Dr. Sue Ross, University of Calgary:

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

Enrollment: 13
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00851864


Locations
Canada, Alberta
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
  More Information

Publications:
Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00851864     History of Changes
Other Study ID Numbers: 05161977
First Submitted: November 18, 2008
First Posted: February 26, 2009
Last Update Posted: August 15, 2013
Last Verified: August 2013

Keywords provided by Dr. Sue Ross, University of Calgary:
anticoagulation
pregnancy

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tinzaparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action