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

Completed · Phase 3

Conditions studied: Soft Tissue Surgical Bleeding

In brief

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.

Key facts

Study ID

NCT01731938

Run by

Grifols Biologicals, LLC

People needed

327

Starts

2012-11-01

Expected to finish

2015-06-01

Last updated by the study team

2017-02-23

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) surgical procedure involving soft (non-parenchymous) tissue.
• Target bleeding site is identified on soft tissue during urologic, gynecologic or general 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 (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
• A target bleeding site can be identified.
• Target bleeding site has moderate bleeding according to the Investigator's judgment.

You may not qualify if…

• Require thoracic, abdominal, 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.
• 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 cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.

Where it is running

• 407 — Florence, Alabama, United States
• 320, 322, 323 — Pasadena, California, United States
• 404 — Bridgeport, Connecticut, United States
• 321 — Boynton Beach, Florida, United States
• 312 — Rochester, Minnesota, United States
• 300 — St Louis, Missouri, United States
• 327 — Albany, New York, United States
• 305 — New York, New York, United States
• 332 — Poughkeepsie, New York, United States
• 304 — Winston-Salem, North Carolina, United States
• 307 — Pittsburgh, Pennsylvania, United States
• 325 — Charleston, South Carolina, United States
• 331 — Chattanooga, Tennessee, United States
• 314 — Memphis, Tennessee, United States
• 402 — Houston, Texas, United States
• 316 — Houston, Texas, United States
• 405 — Tacoma, Washington, United States
• 702 — Budapest, Hungary
• 701 — Debrecen, Hungary
• 700 — Debrecen, Hungary
• 703 — Debrecen, Hungary
• 704 — Győr, Hungary
• 720, 722, 726, 723 — Belgrade, Serbia
• 725 — Niš, Serbia
• 721, 724 — Novi Sad, Serbia

Full record on ClinicalTrials.gov

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