Topical Raplixa for Surgical Bleeding in Children

Phase 2

Terminated

Conditions: Surgical Bleeding

Interventions: Drug: Raplixa
Device: Gelfoam
Drug: Rescue treatment

Registration Number: NCT02117349

Lead Sponsor: Mallinckrodt

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 55

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raplixa plus Gelfoam	Gelfoam	During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate target bleeding site (TBS). The treatment is topically applied using 1 of the following 3 methods: * A thin layer of Raplixa is sprinkled directly from the vial onto the TBS, followed by application of Gelfoam. * A thin layer of Raplixa is sprayed onto the TBS using the RaplixaSpray device, followed by application of Gelfoam. * Raplixa is applied onto moistened Gelfoam which is then applied to the TBS. Manual pressure is applied over the treatments using sterile gauze. The amount of Raplixa and Gelfoam used is at the discretion of the investigator, within the maximum of two 1 gram (g) vials of Raplixa that are permitted for each participant. Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute time-to-hemostasis (TTH) evaluation.
Raplixa plus Gelfoam	Rescue treatment	During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate target bleeding site (TBS). The treatment is topically applied using 1 of the following 3 methods: * A thin layer of Raplixa is sprinkled directly from the vial onto the TBS, followed by application of Gelfoam. * A thin layer of Raplixa is sprayed onto the TBS using the RaplixaSpray device, followed by application of Gelfoam. * Raplixa is applied onto moistened Gelfoam which is then applied to the TBS. Manual pressure is applied over the treatments using sterile gauze. The amount of Raplixa and Gelfoam used is at the discretion of the investigator, within the maximum of two 1 gram (g) vials of Raplixa that are permitted for each participant. Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute time-to-hemostasis (TTH) evaluation.
Gelfoam Only	Gelfoam	During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate TBS. Gelfoam is cut to the appropriate size and applied topically, according to the manufacturer's package insert, followed by manual pressure using sterile gauze. Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute TTH evaluation, if necessary.
Gelfoam Only	Rescue treatment	During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate TBS. Gelfoam is cut to the appropriate size and applied topically, according to the manufacturer's package insert, followed by manual pressure using sterile gauze. Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute TTH evaluation, if necessary.
Raplixa plus Gelfoam	Raplixa	During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate target bleeding site (TBS). The treatment is topically applied using 1 of the following 3 methods: * A thin layer of Raplixa is sprinkled directly from the vial onto the TBS, followed by application of Gelfoam. * A thin layer of Raplixa is sprayed onto the TBS using the RaplixaSpray device, followed by application of Gelfoam. * Raplixa is applied onto moistened Gelfoam which is then applied to the TBS. Manual pressure is applied over the treatments using sterile gauze. The amount of Raplixa and Gelfoam used is at the discretion of the investigator, within the maximum of two 1 gram (g) vials of Raplixa that are permitted for each participant. Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute time-to-hemostasis (TTH) evaluation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (13): Carilion Clinic
🇺🇸
Roanoke, Virginia, United States
SGM Physician Research Consortium, LLC
🇺🇸
Wayne, Pennsylvania, United States
Nemours Children's Specialty Care
🇺🇸
Jacksonville, Florida, United States
Saint Louis Children's Hospital
🇺🇸
Saint Louis, Missouri, United States
Arizona Burn Center at Maricopa Medical Center
🇺🇸
Phoenix, Arizona, United States
Children's Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Shriners Hospital for Children
🇺🇸
Sacramento, California, United States
Children's Healthcare of Atlanta
🇺🇸
Atlanta, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
🇺🇸
Chicago, Illinois, United States
Wake Forest University School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States
St. Christopher's Hospital for Children
🇺🇸
Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas
🇺🇸
Dallas, Texas, United States
Seattle Children's Hospital - PIN
🇺🇸
Seattle, Washington, United States