Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing
Weight-Adjusted Dosing of Tinzaparin in Pregnancy
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 18, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 15, 2013
August 1, 2013
3 years
November 18, 2008
August 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (2)
mean dosage requirement in each trimester
1 year
rate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology
1 year
Study Arms (1)
A
EXPERIMENTALWomen requiring therapeutic anticoagulation, singleton pregnancy,\<30weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- LEO Pharmacollaborator
Study Sites (1)
Calgary Health Region
Calgary, Alberta, T2N 4N1, Canada
Related Publications (1)
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.
PMID: 23245654RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor
Study Record Dates
First Submitted
November 18, 2008
First Posted
February 26, 2009
Study Start
October 1, 2007
Primary Completion
October 1, 2010
Study Completion
May 1, 2011
Last Updated
August 15, 2013
Record last verified: 2013-08