NCT00684047

Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.

Detailed description

The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.

Conditions

• Target Bleeding Site During Peripheral Vascular Surgery

Interventions

Type	Name	Description
BIOLOGICAL	FS Grifols	Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
BIOLOGICAL	FS Grifols	Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
PROCEDURE	Manual Compression	Manual Compression. Primary Part (II)

Timeline

• Start date: 2008-02-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2008-05-26
• Last updated: 2016-01-25
• Results posted: 2016-01-25

Locations

19 sites across 3 countries: Canada, Spain, United Kingdom