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:

University of Calgary

ClinicalTrials.gov Identifier:

NCT00851864

First received: November 18, 2008

Last updated: September 8, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 18, 2008

Last Updated Date

September 8, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00851864 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Weight-Adjusted Dosing of Tinzaparin in Pregnancy

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Venous Thromboembolism

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A

Women requiring therapeutic anticoagulation, singleton pregnancy,<30weeks

Intervention: Drug: Tinzaparin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00851864

Other Study ID Numbers ^ICMJE

05161977

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Paul Gibson/principal investigator, University of Calgary, Faculty of Medicine

Study Sponsor ^ICMJE

University of Calgary

Collaborators ^ICMJE

LEO Pharma

Investigators ^ICMJE

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

Information Provided By

University of Calgary

Verification Date

September 2011

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

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