Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mallinckrodt
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
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
