Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries - Full Text View

Purpose

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.

Condition	Intervention	Phase
Parenchymous 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 Parenchymous 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.


Enrollment:	325
Study Start Date:	December 2012
Study Completion Date:	December 2015
Primary Completion Date:	December 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 (6 mL of solution in total).	Biological: Fibrin Sealant (FS) Grifols 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.
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


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754480

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Sponsors and Collaborators

Instituto Grifols, S.A.

More Information


Responsible Party:	Instituto Grifols, S.A.
ClinicalTrials.gov Identifier:	NCT01754480 History of Changes
Other Study ID Numbers:	IG1102
Study First Received:	December 18, 2012
Last Updated:	January 12, 2016
Health Authority:	United States: Food and Drug Administration Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Hungary: National Institute of Pharmacy Serbia: Medicines and Medical Devices Agency Russia: Ministry of Health of the Russian Federation

Keywords provided by Grifols Biologicals Inc.:


Fibrin Sealant Parenchymous tissue open surgery Hepatic Resection Oxidized cellulose pads

Additional relevant MeSH terms:


Fibrin Tissue Adhesive Hemostatics Coagulants

ClinicalTrials.gov processed this record on September 23, 2016