FS Grifols in Vascular Surgery, IG402, Final Version 2.1
Research type
Research Study
Full title
A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis during Peripheral Vascular Surgery
IRAS ID
684
Sponsor organisation
Instituto Grifols S.A:
Eudract number
2008-000072-25
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess the safety and the efficacy of a new fibrin sealant product named FSGrifols in achieving hemostasis (cessation of bleeding) during peripheral vascular surgery in comparison to manual compression (standard technique used during surgery for this purpose). Human plasma-derived FS Grifols will be applied to arteries with mild (oozing and capillary) or moderate (gradual and steady) bleeding. FS Grifols will be used for the first time on humans in this study. Subjects undergoing an elective peripheral vascular surgery will be candidates to enter the study. Subjects will receive one of two possible treatments: FS Grifols or manual pressure will be applied to the bleeding site, if any, during surgery. At each study center, at least the first two participants will be treated only with FS Grifols to allow familiarisation in the study procedures as well as in application techniques and for initially assessing clinical safety of the product. The following participants will be randomly assigned in a 2:1 ratio into FS Grifols or manual pressure treatment to assess safety and efficacy of the product.
REC name
North West - Haydock Research Ethics Committee
REC reference
08/H1010/54
Date of REC Opinion
29 Oct 2008
REC opinion
Further Information Favourable Opinion