Non-safety device related issues

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.

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

modified Intent-to-treat (ITT)

within 97 days

All-cause mortality is reported in the Intent-to-treat population (37/18) to include one who was randomized, but died before treatment.

Serious and Other Adverse events are reported in the Safety population (36/18), defined as randomized participants who were exposed to study drug (group based on actual treatment received).