At a glance
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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 Parenchymous Tissue Open Surgeries
In Brief
A Phase 3 clinical trial evaluating Fibrin Sealant Grifols and Surgicel® for Parenchymous Tissue Surgical Bleeding. Completed, enrolled 325 participants across 33 sites in 4 countries.
Detailed Summary
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
Study Details
Timeline
Interventions
Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.