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

NCT ID: NCT00851864

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Venous Thromboembolism

Keywords

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anticoagulation pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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A

Women requiring therapeutic anticoagulation, singleton pregnancy,\<30weeks

Group Type EXPERIMENTAL

Tinzaparin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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innohep

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sue Ross

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Gibson, M.D. FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Kendra Newell, M.D.

Role: STUDY_CHAIR

University of Calgary

David Sam, M.D. FRCPC

Role: STUDY_CHAIR

University of Calgary

Locations

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Calgary Health Region

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 23245654 (View on PubMed)

Other Identifiers

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05161977

Identifier Type: -

Identifier Source: org_study_id