Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

Summary

The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT). The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.

Timeline

Start

2005-12

Primary completion

2008-05

Completion

2008-07

Publications

• Leizorovicz A, Siguret V, Mottier D; Innohep(R) in Renal Insufficiency Study Steering Committee; Leizorovicz A, Siguret V, Mottier D, Clonier F, Janas M, Stinson J, Townshend G, Maddalena M. Safety profile of tinzaparin versus subcutaneous unfractionated heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis: the Innohep(R) in Renal Insufficiency Study (IRIS). Thromb Res. 2011 Jul;128(1):27-34. doi: 10.1016/j.thromres.2011.03.002. Epub 2011 Apr 7.

Drugs

Indications