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Topical Raplixa for Surgical Bleeding in Children

Primary Purpose

Surgical Bleeding

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Raplixa
Gelfoam
Rescue treatment
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Bleeding focused on measuring surgical hemostasis, bleeding, fibrin sealant, fibrinogen, thrombin, spray dried

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Burn Center at Maricopa Medical Center
  • Children's Hospital Los Angeles
  • Shriners Hospital for Children
  • Nemours Children's Specialty Care
  • Children's Healthcare of Atlanta
  • Ann and Robert H Lurie Childrens Hospital of Chicago
  • Saint Louis Children's Hospital
  • Wake Forest University School of Medicine
  • St. Christopher's Hospital for Children
  • SGM Physician Research Consortium, LLC
  • Children's Medical Center Dallas
  • Carilion Clinic
  • Seattle Children's Hospital - PIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Raplixa plus Gelfoam

Gelfoam Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 14, 2014
Last Updated
February 3, 2020
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT02117349
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Non-safety device related issues
Study Start Date
December 4, 2014 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
March 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Bleeding
Keywords
surgical hemostasis, bleeding, fibrin sealant, fibrinogen, thrombin, spray dried

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raplixa plus Gelfoam
Arm Type
Experimental
Arm Description
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.
Arm Title
Gelfoam Only
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Raplixa
Other Intervention Name(s)
Fibrin Sealant [Human], Fibrocaps
Intervention Description
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
Device
Intervention Name(s)
Gelfoam
Other Intervention Name(s)
Gelfoam 50, Gelfoam 100
Intervention Description
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
Drug
Intervention Name(s)
Rescue treatment
Other Intervention Name(s)
Standard Care
Intervention Description
Thrombin-containing hemostats included in standard care at the site
Primary Outcome Measure Information:
Title
Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes
Description
Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application
Time Frame
within 4 minutes
Secondary Outcome Measure Information:
Title
Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes
Description
Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application
Time Frame
within 5 minutes
Title
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
within 97 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Burn Center at Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Shriners Hospital for Children
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Nemours Children's Specialty Care
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ann and Robert H Lurie Childrens Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Saint Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
SGM Physician Research Consortium, LLC
City
Wayne
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
90027
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013
Country
United States
Facility Name
Seattle Children's Hospital - PIN
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Topical Raplixa for Surgical Bleeding in Children

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