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

Completed · Phase 3

Conditions studied: Parenchymous Tissue Surgical Bleeding

In brief

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.

Key facts

Study ID

NCT01754480

Run by

Instituto Grifols, S.A.

People needed

325

Starts

2013-03-01

Expected to finish

2015-12-01

Last updated by the study team

2017-02-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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