Topical Raplixa for Surgical Bleeding in Children

NCT02117349 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: FC-007
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 13

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

Keywords

surgical hemostasis; bleeding; fibrin sealant; fibrinogen; thrombin; spray dried

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes

  within 5 minutes

• Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)

  within 97 days

Study Arms (2)

Raplixa plus Gelfoam

EXPERIMENTAL

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.

Drug: Raplixa; Device: Gelfoam; Drug: Rescue treatment

Gelfoam Only

OTHER

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.

Device: Gelfoam; Drug: Rescue treatment

Interventions

Raplixa 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.

Also known as: Fibrin Sealant [Human], Fibrocaps

Raplixa plus Gelfoam

Gelfoam 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.

Also known as: Gelfoam 50, Gelfoam 100

Gelfoam Only; Raplixa plus Gelfoam

Rescue treatment DRUG

Thrombin-containing hemostats included in standard care at the site

Also known as: Standard Care

Gelfoam Only; Raplixa plus Gelfoam

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (13)

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Shriners Hospital for Children

Sacramento, California, 95817, United States

Location

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

SGM Physician Research Consortium, LLC

Wayne, Pennsylvania, 19087, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 90027, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

Seattle Children's Hospital - PIN

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrin Tissue Adhesive; Gelatin Sponge, Absorbable; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Surgical Sponges; Surgical Equipment; Equipment and Supplies; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 17, 2014
• Study Start: December 4, 2014
• Primary Completion: November 17, 2017
• Study Completion: March 6, 2018
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)