Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
Condition: Parenchymous Tissue Surgical Bleeding
Intervention: Fibrin Sealant Grifols; Surgicel®
Intervention description: 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.; Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 325.0
Sex: All
Healthy volunteers: No
Keywords: Fibrin Sealant; Parenchymous tissue open surgery; Hepatic Resection; Oxidized cellulose pads

Summary:

      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.
    

Eligibility criteria:

        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.