Topical Raplixa for Surgical Bleeding in Children

NCT ID: NCT02117349

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-04
• Study Completion Date: 2018-03-06

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.

Conditions

Surgical Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Raplixa plus 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.

Group Type: EXPERIMENTAL

Raplixa

Intervention Type: DRUG

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

Intervention Type: DEVICE

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

Intervention Type: DRUG

Thrombin-containing hemostats included in standard care at the site

Gelfoam Only

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.

Group Type: OTHER

Gelfoam

Intervention Type: DEVICE

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

Intervention Type: DRUG

Thrombin-containing hemostats included in standard care at the site

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Rescue treatment

Thrombin-containing hemostats included in standard care at the site

Intervention Type: DRUG

Other Intervention Names

Fibrin Sealant [Human]; Fibrocaps; Gelfoam 50; Gelfoam 100; Standard Care

Eligibility Criteria

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

• 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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

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

Nemours Children's Specialty Care

Jacksonville, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Saint Louis Children's Hospital

St Louis, Missouri, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

SGM Physician Research Consortium, LLC

Wayne, Pennsylvania, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Seattle Children's Hospital - PIN

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FC-007

Identifier Type: -

Identifier Source: org_study_id