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

NCT ID: NCT01754480

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Fibrin Sealant 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).

Group Type: EXPERIMENTAL

Fibrin Sealant Grifols

Intervention Type: 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.

Surgicel®

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

Group Type: ACTIVE_COMPARATOR

Surgicel®

Intervention Type: DEVICE

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

Interventions

Fibrin Sealant 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.

Intervention Type: BIOLOGICAL

Surgicel®

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

Intervention Type: DEVICE

Other Intervention Names

Fibrillar absorbable hemostat; Oxidized regenerated cellulose hemostat

Eligibility 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 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

224

Loma Linda, California, United States

214

Los Angeles, California, United States

213

New Haven, Connecticut, United States

223

Augusta, Georgia, United States

228

Chicago, Illinois, United States

227

Goshen, Indiana, United States

207

Louisville, Kentucky, United States

220

New Orleans, Louisiana, United States

229

Bethesda, Maryland, United States

201

St Louis, Missouri, United States

231

Las Vegas, Nevada, United States

200

Albany, New York, United States

211

New York, New York, United States

212

New York, New York, United States

230

Charlotte, North Carolina, United States

233

Cincinnati, Ohio, United States

400

Hershey, Pennsylvania, United States

218

Philadelphia, Pennsylvania, United States

204

Philadelphia, Pennsylvania, United States

205

Charleston, South Carolina, United States

217

Memphis, Tennessee, United States

206

Nashville, Tennessee, United States

216, 219

Houston, Texas, United States

232

Salt Lake City, Utah, United States

226

Charlottesville, Virginia, United States

202

Madison, Wisconsin, United States

602

Budapest, , Hungary

600

Pécs, , Hungary

640

Moscow, , Russia

641

Saint Petersburg, , Russia

621, 622, 623

Belgrade, , Serbia

620, 625

Niš, , Serbia

624

Novi Sad, , Serbia

Countries

United States; Hungary; Russia; Serbia

Other Identifiers

IG1102

Identifier Type: -

Identifier Source: org_study_id