Topical Raplixa for Surgical Bleeding in Children

Surgical Bleeding Clinical Trial

Official title:

A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02117349
• Other study ID #: FC-007
• Status: Terminated
• Phase: Phase 2
• Start date: December 4, 2014
• Est. completion date: March 6, 2018

Study information

• Verified date: February 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: March 6, 2018
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Surgical Bleeding

Intervention

Drug:
• Raplixa
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.

Device:
• Gelfoam
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.

Drug:
• Rescue treatment
Thrombin-containing hemostats included in standard care at the site

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes	Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application	within 4 minutes
Secondary	Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes	Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application	within 5 minutes
Secondary	Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)	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.	within 97 days