Topical Raplixa for Surgical Bleeding in Children

• Status: Terminated
• Trial end date: 2018-03-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Fibrin Tissue Adhesive; Gelatin Sponge, Absorbable

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