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

Phase 4 Completed 13 enrolled University of Calgary LEO Pharma · collab

NaSingle-groupOpen-label

Summary

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

Timeline

Start: 2007-10
Primary completion: 2010-10
Completion: 2011-05

Outcome

Missed primary endpoint

paper Weight-based dosing failed to maintain therapeutic anticoagulation in 11 (92%) of women PMID 23245654 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tinzaparin	Other / unclassified	175 iu/kg	Subcutaneous