Surgical BleedingPhase 2NCT02117349
Topical Raplixa for Surgical Bleeding in Children
A Phase 2 study testing Raplixa, Gelfoam and Rescue treatment in people with Surgical Bleeding, run by Mallinckrodt at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Surgical Bleeding
- What is being tested?
- Raplixa, Gelfoam and Rescue treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 13 sitesUnited States
- Study dates
- 4 Dec 2014to 6 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
Children's Medical Center Dallas
Dallas, Texas, 90027
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
Children's Hospital Los Angeles
Los Angeles, California, 90027
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, 85008
Carilion Clinic
Roanoke, Virginia, 24013
Shriners Hospital for Children
Sacramento, California, 95817
Seattle Children's Hospital - PIN
Seattle, Washington, 98105
Saint Louis Children's Hospital
St Louis, Missouri, 63110
SGM Physician Research Consortium, LLC
Wayne, Pennsylvania, 19087
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
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
- Being tested
- Raplixa, Gelfoam, Rescue treatment
- Keywords
- surgical hemostasis, bleeding, fibrin sealant, fibrinogen, thrombin, spray dried
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaplixaDrug
Also called Fibrin Sealant [Human], Fibrocaps
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.
GelfoamDevice
Also called Gelfoam 50, Gelfoam 100
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 treatmentDrug
Also called Standard Care
Thrombin-containing hemostats included in standard care at the site
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Gelfoam; Drug: Rescue treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 4 minutes
Secondary outcomes (2)
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
Measured: within 5 minutes
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.
Measured: within 97 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study start4 Dec 2014
- Primary completion17 Nov 2017
- Study completion6 Mar 2018
Why it stopped: Non-safety device related issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117349
- Sponsor's protocol ID
- FC-007
- Status last verified
- Feb 2020
- First submitted
- 14 Apr 2014
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
- ClinicalTrials.gov ID
- NCT02117349
- Acronym / sponsor ID
- FC-007
- Conditions
- Surgical Bleeding
- Keywords
- surgical hemostasis, bleeding, fibrin sealant, fibrinogen, thrombin, spray dried
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Non-safety device related issues
- Enrolment
- 55 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2014 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raplixa plus Gelfoam | Experimental | Drug: Raplixa, Device: Gelfoam, Drug: Rescue treatmentDuring 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. |
| Gelfoam Only | Other | Device: Gelfoam, Drug: Rescue treatmentDuring 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaplixaAlso: Fibrin Sealant [Human], FibrocapsRaplixa 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. | Drug | Raplixa plus Gelfoam |
| GelfoamAlso: Gelfoam 50, Gelfoam 100Gelfoam 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. | Device | Gelfoam Only, Raplixa plus Gelfoam |
| Rescue treatmentAlso: Standard CareThrombin-containing hemostats included in standard care at the site | Drug | Gelfoam Only, Raplixa plus Gelfoam |
Primary outcome
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
2 secondary outcomes
Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes
Time frame: within 5 minutes
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Time frame: within 97 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Mallinckrodt
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raplixa, Gelfoam and Rescue treatment in people with Surgical Bleeding, run by Mallinckrodt at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes (time frame: within 4 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.