Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous 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 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.

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 Parenchymous Tissue Open Surgeries

Conditions
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Parenchymous Tissue Surgical Bleeding

Intervention / Treatment
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* Biological: Fibrin Sealant 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), 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. Exclusion Criteria: 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.
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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrin Sealant 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 Grifols<br>* 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.<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 |
| --- | --- | --- |
| Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start | Subjects achieving hemostasis at the target bleeding site by 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 |
| --- | --- | --- |
| Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start | Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure. | From start of treatment until 3 minutes after treatment start | 
| Time to Hemostasis | Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start. | From start of treatment until 10 minutes after treatment start | 
| Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points | Cumulative proportion of subjects having achieved hemostasis by each of the following time points: At 2 minutes following start of study treatment At 5 minutes following start of study treatment At 7 minutes following start of study treatment At 10 minutes following start of study treatment | From start of treatment until 10 minutes after treatment start | 
| Prevalence of Treatment Failures | Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment. | From start of treatment until 10 minutes after treatment start | 

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