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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Soft Tissue Surgical Bleeding

Intervention / Treatment
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* Biological: Fibrin Sealant (FS) Grifols
* Device: Surgicel®


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrin Sealant (FS) Grifols<br>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<br>* Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).<br>|
| Active Comparator: Surgicel®<br>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. | Device: Surgicel®<br>* Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.<br>* Other names: Oxidized regenerated cellulose hemostat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving Hemostasis Within 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. | From start of treatment until 4 minutes after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis (TTH) | 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. | From start of treatment to the end of the 10-minute observational period | 
| 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 | 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. | From start of treatment to time of completion of surgical closure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft tissue open surgery, Oxidized cellulose pads, Fibrin Sealant