- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851864
Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing
August 14, 2013 updated by: Dr. Sue Ross, University of Calgary
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- Calgary Health Region
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A
Women requiring therapeutic anticoagulation, singleton pregnancy,<30weeks
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
anti-Xa level Day 1,28, then q4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean dosage requirement in each trimester
Time Frame: 1 year
|
1 year
|
rate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (ACTUAL)
October 1, 2010
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
February 25, 2009
First Posted (ESTIMATE)
February 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 15, 2013
Last Update Submitted That Met QC Criteria
August 14, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05161977
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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