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Trial record 1 of 1 for:    02117349
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Topical Raplixa for Surgical Bleeding in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117349
Recruitment Status : Terminated (Non-safety device related issues)
First Posted : April 17, 2014
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Surgical Bleeding Drug: Raplixa Device: Gelfoam Drug: Rescue treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
Actual Study Start Date : December 4, 2014
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : March 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Raplixa

Arm Intervention/treatment
Experimental: 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.

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.
Other Names:
  • Fibrin Sealant [Human]
  • Fibrocaps

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.
Other Names:
  • Gelfoam 50
  • Gelfoam 100

Drug: Rescue treatment
Thrombin-containing hemostats included in standard care at the site
Other Name: Standard Care

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.

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.
Other Names:
  • Gelfoam 50
  • Gelfoam 100

Drug: Rescue treatment
Thrombin-containing hemostats included in standard care at the site
Other Name: Standard Care




Primary Outcome Measures :
  1. Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes [ Time Frame: within 4 minutes ]
    Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application


Secondary Outcome Measures :
  1. Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes [ Time Frame: within 5 minutes ]
    Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application

  2. Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117349


Locations
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United States, Arizona
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Shriners Hospital for Children
Sacramento, California, United States, 95817
United States, Florida
Nemours Children's Specialty Care
Jacksonville, Florida, United States, 32207
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Missouri
Saint Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
SGM Physician Research Consortium, LLC
Wayne, Pennsylvania, United States, 19087
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 90027
United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24013
United States, Washington
Seattle Children's Hospital - PIN
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Mallinckrodt:
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02117349    
Other Study ID Numbers: FC-007
First Posted: April 17, 2014    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mallinckrodt:
surgical hemostasis
bleeding
fibrin sealant
fibrinogen
thrombin
spray dried
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Gelatin Sponge, Absorbable
Hemostatics
Coagulants