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

This study has been completed.
Information provided by (Responsible Party):
Grifols Biologicals Inc. Identifier:
First received: November 19, 2012
Last updated: October 14, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Soft 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 Soft 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: 327
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: April 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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01731938

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Sponsors and Collaborators
Grifols Biologicals Inc.
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc. Identifier: NCT01731938     History of Changes
Other Study ID Numbers: IG1103 
Study First Received: November 19, 2012
Last Updated: October 14, 2015
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

Keywords provided by Grifols Biologicals Inc.:
Fibrin Sealant
Soft tissue open surgery
Oxidized cellulose pads

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 04, 2016