Topical Raplixa for Surgical Bleeding in Children
Condition: Surgical Bleeding
MeSH terms: Hemorrhage
Intervention: Raplixa; Gelfoam; Rescue treatment
Intervention description: Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding.; Gelfoam Sterile Sponge is a medical device (USP, Pfizer) intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product. It may be cut without fraying, used wet or dry, and is able to absorb many times its weight in blood and other fluids.; Thrombin-containing hemostats included in standard care at the site
Intervention MeSH terms: Fibrin Tissue Adhesive; Gelatin Sponge, Absorbable
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 55.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: surgical hemostasis; bleeding; fibrin sealant; fibrinogen; thrombin; spray dried

Summary:

      The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone
      in stopping mild to moderate bleeding in children having surgery.
    

Eligibility criteria:

        Before Surgery Inclusion Criteria:

          -  Was at least 36 weeks gestational age at birth (if an infant less than 6 months old)
             and is no older than 17 years at time of treatment

          -  Has a legal representative (parent or guardian) who signed an institutional review
             board (IRB)-approved informed consent document

          -  If at least 7 years old or appropriate age as defined by local regulations, may be
             required to sign an IRB-approved assent document

          -  Is scheduled to undergo one of the surgical procedures described in the protocol

          -  If female and of child-bearing potential, subject has negative pregnancy test on the
             day of surgery (baseline)

          -  If a sexually active male or female of reproductive potential, agrees to use a
             medically accepted form of contraception from the time of consent to completion of all
             follow-up study visits

        During Surgery Inclusion Criteria:

          -  Has mild or moderate bleeding/oozing

          -  Has TBS surface area no more than 100 cm^2

          -  Has not received any whole blood, fresh frozen plasma (FFP), cryoprecipitate, or
             platelets within 24 hours prior to study drug (packed red blood cell (PRBC)
             transfusions are allowed)

          -  Had no complication during surgery other than bleeding which, in the opinion of the
             Investigator, may interfere with the assessment of efficacy or safety

        Exclusion Criteria:

          -  Has any clinically significant laboratory or vital sign value, chronic disease state,
             or congenital coagulation disorder (eg, hemophilia A or B) that the investigator
             determines could interfere with the assessment of efficacy or pose a safety risk to
             the participant

          -  Is unwilling to receive blood products

          -  Has known antibodies or hypersensitivity to porcine gelatine, Raplixa or any of it's
             components, or other thrombin preparations or coagulation factors

          -  Has medical, social, or psychosocial factors that, in the opinion of the Investigator,
             could impact safety of the participant or compliance with study procedures, including
             protocol-defined limits on participating in other clinical studies