NCT01662856

Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

A Prospective, Single-blind, Randomized, Phase 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 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.

Conditions

• Vascular Surgical Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	Fibrin Sealant Grifols	Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
PROCEDURE	Manual Compression	Direct manual compression of target bleeding site with gauze/laparotomy pads.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-08-10
• Last updated: 2017-04-06
• Results posted: 2017-04-06

Locations

38 sites across 4 countries: United States, Hungary, Russia, Serbia