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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Fibrin Sealant (FS) Grifols	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).
Surgicel®	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start	From start of treatment until 4 minutes after treatment start	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.

Secondary Outcome Measures

Name	Time	Method
Time to Hemostasis (TTH)	From start of treatment to the end of the 10-minute observational period	TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.
Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.	From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
Treatments Failures	From start of treatment to time of completion of surgical closure.	The following were considered treatment failures: Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.

Locations (25): 404
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Bridgeport, Connecticut, United States
407
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Florence, Alabama, United States
320, 322, 323
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Pasadena, California, United States
321
🇺🇸
Boynton Beach, Florida, United States
312
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Rochester, Minnesota, United States
327
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Albany, New York, United States
300
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Saint Louis, Missouri, United States
332
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Poughkeepsie, New York, United States
305
🇺🇸
New York, New York, United States
331
🇺🇸
Chattanooga, Tennessee, United States
325
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Charleston, South Carolina, United States
405
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Tacoma, Washington, United States
307
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Pittsburg, Pennsylvania, United States
304
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Winston Salem, North Carolina, United States
314
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Memphis, Tennessee, United States
702
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Budapest, Hungary
701
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Debrecen, Hungary
700
🇭🇺
Debrecen, Hungary
725
🇷🇸
Niš, Serbia
402
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Houston, Texas, United States
316
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Houston, Texas, United States
704
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Győr, Hungary
703
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Debrecen, Hungary
721, 724
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Novi Sad, Serbia
720, 722, 726, 723
🇷🇸
Beograd, Serbia