Topical Raplixa for Surgical Bleeding in Children

• Raplixa (Drug), also known as Fibrin Sealant [Human], Fibrocaps: 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 (Device), also known as Gelfoam 50, Gelfoam 100: 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.
• Rescue treatment (Drug), also known as Standard Care: Thrombin-containing hemostats included in standard care at the site

Primary outcomes

• Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes [within 4 minutes]: Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application

Secondary outcomes

• Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes [within 5 minutes]: Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application
• Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) [within 97 days]: Clinically significant changes in safety measures are recorded as adverse events. Participants with TEAEs that are deemed by the principal investigator or the independent data monitoring committee as possibly or definitely treatment-related (including device-related) are included in the count for this secondary outcome measure.

Sex: All, ages: any to 17 Years

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

Participant flow

Outcome results

• Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes (Primary), Count of participants, Participants: Raplixa Plus Gelfoam 30; Gelfoam Alone 5 (p = 0.0010)
• Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes (Secondary), Count of participants, Participants: Raplixa Plus Gelfoam 33; Gelfoam Alone 7
• Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) (Secondary), Count of participants, Participants: Raplixa Plus Gelfoam 0; Gelfoam Alone 0

Adverse events

Time frame: within 97 days

Serious adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2016-07-13)

• Global Clinical Leader, Study director, Mallinckrodt