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

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
ClinicalTrials.gov Identifier:
NCT00851864
First received: November 18, 2008
Last updated: August 14, 2013
Last verified: August 2013

November 18, 2008
August 14, 2013
October 2007
October 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00851864 on ClinicalTrials.gov Archive Site
  • mean dosage requirement in each trimester [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • rate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing
Weight-Adjusted Dosing of Tinzaparin in Pregnancy

The purpose of this study is to evaluate the safety and efficacy of therapeutic anticoagulation with tinzaparin during pregnancy via weight-based dosing.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Venous Thromboembolism
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
Experimental: A
Women requiring therapeutic anticoagulation, singleton pregnancy,<30weeks
Intervention: Drug: Tinzaparin
Gibson PS, Newell K, Sam DX, Mansoor A, Jiang X, Tang S, Ross S. Weight-adjusted dosing of tinzaparin in pregnancy. Thromb Res. 2013 Feb;131(2):e71-5. doi: 10.1016/j.thromres.2012.11.018. Epub 2012 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2011
October 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00851864
05161977
Yes
Dr. Sue Ross, University of Calgary
University of Calgary
LEO Pharma
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
University of Calgary
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP