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

NCT01754480 | Completed Phase 3 Results

• 1 other identifier: IG1102
• Study Type: interventional
• Target: 325
• Locations: 4 countries
• Sites: 33

Brief 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.

Conditions

Parenchymous Tissue Surgical Bleeding

Keywords

Fibrin Sealant; Parenchymous tissue open surgery; Hepatic Resection; Oxidized cellulose pads

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start

  Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.

  From start of treatment until 4 minutes after treatment start

Secondary Outcomes (4)

• Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start

  From start of treatment until 3 minutes after treatment start

• Time to Hemostasis

  From start of treatment until 10 minutes after treatment start

• Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points

  From start of treatment until 10 minutes after treatment start

• Prevalence of Treatment Failures

  From start of treatment until 10 minutes after treatment start

Study Arms (2)

Fibrin Sealant Grifols

EXPERIMENTAL

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 Grifols

Surgicel®

ACTIVE COMPARATOR

Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Device: Surgicel®

Interventions

Fibrin Sealant Grifols BIOLOGICAL

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.

Fibrin Sealant Grifols

Surgicel® DEVICE

Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Also known as: Fibrillar absorbable hemostat, Oxidized regenerated cellulose hemostat

Surgicel®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 Fibrin Sealant 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.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (33)

224

Loma Linda, California, 92354, United States

Location

214

Los Angeles, California, 90033, United States

Location

213

New Haven, Connecticut, 06520, United States

Location

223

Augusta, Georgia, 30912, United States

Location

228

Chicago, Illinois, 60611, United States

Location

227

Goshen, Indiana, 46526, United States

Location

207

Louisville, Kentucky, 40202, United States

Location

220

New Orleans, Louisiana, 70112, United States

Location

229

Bethesda, Maryland, 20889, United States

Location

201

St Louis, Missouri, 63110, United States

Location

231

Las Vegas, Nevada, 89102, United States

Location

200

Albany, New York, 12208, United States

Location

211

New York, New York, 10029, United States

Location

212

New York, New York, 10032, United States

Location

230

Charlotte, North Carolina, 28204, United States

Location

233

Cincinnati, Ohio, 45219, United States

Location

400

Hershey, Pennsylvania, 17033, United States

Location

218

Philadelphia, Pennsylvania, 19102, United States

Location

204

Philadelphia, Pennsylvania, 19107, United States

Location

205

Charleston, South Carolina, 29425, United States

Location

217

Memphis, Tennessee, 38104, United States

Location

206

Nashville, Tennessee, 37232-7610, United States

Location

216, 219

Houston, Texas, 77030, United States

Location

232

Salt Lake City, Utah, 84132, United States

Location

226

Charlottesville, Virginia, 22908, United States

Location

202

Madison, Wisconsin, 53792, United States

Location

602

Budapest, 1082, Hungary

Location

600

Pécs, 7623, Hungary

Location

640

Moscow, 115478, Russia

Location

641

Saint Petersburg, 197758, Russia

Location

621, 622, 623

Belgrade, 11000, Serbia

Location

620, 625

Niš, 18000, Serbia

Location

624

Novi Sad, 21000, Serbia

Location

Results Point of Contact

• Title: Henry Li, PhD
• Organization: Grifols Therapeutics Inc

henry.li@grifols.com

+1 919 316 6042

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Locations

US (26); HU (2); SE (3); RU (2)