A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
Condition: Excessive Bleeding During Surgery
Intervention: Fibrin Sealant Grifols; EVICEL
Intervention description: The FE Grifols solution was applied topically via drip or spray application.; The EVICEL solution was applied topically via drip or spray application.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 186.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms
      of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4
      minutes (T4) from the start of treatment application (TStart) with no occurrence of
      rebleeding until the completion of the surgical closure by layers of the exposed surgical
      field containing the TBS (TClosure).
    

Eligibility criteria:

        Inclusion Criteria:

        Pre-operative:

          1. Less than 18 years of age.

          2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or
             thoracic (non-cardiac) surgical procedure.

          3. Participant and/or participant's legal guardian is willing to give permission for the
             participant to participate in the clinical trial and provide written informed consent
             for the participant. In addition, assent must be obtained from pediatric participants
             who possess the intellectual and emotional ability to comprehend the concepts involved
             in the clinical trial.

             Intra-operative:

          4. Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft
             tissue TBS identified intra-operatively by the investigator (the surgeon).

          5. TBS has Grade 1 (mild) or Grade 2 (moderate) bleeding intensity according to the
             investigator's (the surgeon's) judgment. The intensity of the bleeding at the TBS will
             be rated by the investigator using the 5-point validated bleeding severity scale.

        Exclusion Criteria:

        Pre-operative:

          1. Admitted for trauma surgery.

          2. Unwilling to receive blood products.

          3. Known history of severe (eg, anaphylactic) reaction to blood products.

          4. Known history of intolerance to any of the components of the investigational product
             (IP).

          5. Female participants who are pregnant, breastfeeding or, if of child-bearing potential
             (ie, adolescent), unwilling to practice a highly effective method of contraception.

          6. Previously enrolled in a clinical trial with FS Grifols.

          7. Currently participating, or during the study is planned to participate, in any other
             investigational device or medicinal product study without prior and explicit approval
             from the sponsor.

             Intra-operative:

          8. An appropriate parenchymous or soft tissue TBS (as defined in exclusion criteria 9 and
             10) cannot be identified intra-operatively by the investigator (the surgeon).

          9. TBS has Grade 3 (severe) bleeding according to the investigator's (the surgeon's)
             judgment that cannot be controlled with conventional surgical techniques to Grade 1 or
             Grade 2 bleeding. The intensity of the bleeding at the TBS will be rated by the
             investigator using the 5-point validated bleeding severity scale.

         10. TBS is in an actively infected surgical field.

         11. Occurrence of major intra-operative complications that require resuscitation or
             deviation from the planned surgical procedure.

         12. Application of any topical hemostatic agent on the resection surface of parenchyma or
             soft tissue prior to application of the IP.