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

This study is currently recruiting participants.

Verified March 2013 by Grifols Biologicals Inc.

Sponsor:

Information provided by (Responsible Party):

Grifols Biologicals Inc.

ClinicalTrials.gov Identifier:

NCT01731938

First received: November 19, 2012

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Purpose

This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. 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.

Condition	Intervention	Phase
Soft Tissue Surgical Bleeding	Biological: Fibrin Sealant (FS) Grifols Device: Surgicel®	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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 Soft Tissue Open Surgeries

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:

Proportion of subjects achieving hemostasis within four minutes after treatment start [ Time Frame: From start of treatment until 4 minutes after treatment start ] [ Designated as safety issue: No ]
Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.

Estimated Enrollment:	344
Study Start Date:	November 2012
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fibrin Sealant (FS) Grifols Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder.	Biological: Fibrin Sealant (FS) Grifols Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder, applied topically to the target bleeding site.
Active Comparator: Surgicel® Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.	Device: Surgicel® Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. Other Names: Fibrillar absorbable hemostat Oxidized regenerated cellulose hemostat

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hemoglobin (Hgb) ≥ 9.0 g/dL
Require elective (non-emergency), open (non-laparoscopic), retroperitoneal or pelvic surgery involving soft (non-parenchymous) tissue.
Target bleeding site is identified on soft tissue during urologic, gynecologic or general retroperitoneal or pelvic surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies, and 8) Retroperitoneal tumor resections.
A target bleeding site can be identified.
Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

Require retroperitoneal or pelvic surgery 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.
Known (documented) previous exposure to thrombin-containing products.
Females who are pregnant or nursing a child.
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 cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731938

Contacts

Contact: Paul Pinciaro, PhD

paul.pinciaro@grifols.com

Locations

United States, Ohio
	Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
	Recruiting
Hershey, Pennsylvania, United States, 17033
	Recruiting
Pittsburg, Pennsylvania, United States, 15224
United States, Texas
	Recruiting
Houston, Texas, United States, 77024

Sponsors and Collaborators

Grifols Biologicals Inc.

More Information

No publications provided

Responsible Party:	Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:	NCT01731938 History of Changes
Other Study ID Numbers:	IG1103
Study First Received:	November 19, 2012
Last Updated:	March 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Grifols Biologicals Inc.:

Fibrin Sealant
Soft tissue open surgery
Retroperitoneal surgery
Pelvic surgery
Oxidized cellulose pads

Additional relevant MeSH terms:

Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics

Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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