Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Phase 2 Completed 30 enrolled OMRIX Biopharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Timeline

Start: 2008-02
Primary completion: 2008-11
Completion: 2009-02

Publications

Nativ O, Patel B, Shen J, Batiller J, Horn S, Hart JC. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study. BMC Nephrol. 2012 Nov 8;13:147. doi: 10.1186/1471-2369-13-147.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fleece	Unknown	—	—

Indications

No indication recorded.