Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

Status:	Completed
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	December 2012
End Date:	December 2015

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

This study is designed to assess the safety and efficacy of fibrin sealant (FS) 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 FS 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 FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS
Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS
Grifols or Surgicel.

Inclusion Criteria:

- Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical
procedure).

- Require elective (non-emergency), open (non-laparoscopic), hepatic resection
(anatomic or non-anatomic resections of at least one anatomical hepatic segment, or
equivalent tissue volume).

- A target bleeding site can be identified.

- Target bleeding site is identified on the cut raw liver surface (resection area).

- Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

- Require hepatic resection due to trauma.

- Infection in the anatomic surgical area.

- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived
product.

- Previous known sensitivity to any FS Grifols component or any Surgicel® component.

- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to
surgical procedure).

- Receiving an organ transplant during the same surgical procedure.

- Undergone a therapeutic surgical procedure within 30 days from the screening visit.

- A target bleeding site cannot be identified.

- The target bleeding site has a mild or severe bleeding.

- Occurrence of major intraoperative complications that require resuscitation or
deviation from the planned surgical procedure.

- Application of any topical haemostatic material on the resection surface of the liver
prior to application of study treatment.

- Radiofrequency precoagulation of the liver resection surface, except focal use of
radiofrequency as primary haemostatic treatment.

We found this trial at

sites

Clinical Trial Facility in New Haven Connecticut

New Haven, Connecticut

from

New Haven, CT