Clinical trial NCT02117349: Topical Raplixa for Surgical Bleeding in Children
Official title: A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Surgical Bleeding
Keywords: surgical hemostasis
bleeding
fibrin sealant
fibrinogen
thrombin
spray dried
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 55
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes
timeFrame: within 4 minutes
Secondary outcomes:
measure: Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes
timeFrame: within 5 minutes
measure: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
timeFrame: within 97 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Sacramento
country: United States
facility: Shriners Hospital for Children
state: California
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann and Robert H Lurie Childrens Hospital of Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Saint Louis Children's Hospital
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Wayne
country: United States
facility: SGM Physician Research Consortium, LLC
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital - PIN
state: Washington
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: