Topical Raplixa for Surgical Bleeding in Children

Study Overview
=================
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.

Official Title
-----------------
A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population

Conditions
-----------------
Surgical Bleeding

Intervention / Treatment
-----------------
* Drug: Raplixa
* Device: Gelfoam
* Drug: Rescue treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raplixa plus Gelfoam<br>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<br>* 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.<br>* Other names: Fibrocaps;Device: Gelfoam<br>* 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.<br>* Other names: Gelfoam 100;Drug: Rescue treatment<br>* Thrombin-containing hemostats included in standard care at the site<br>* Other names: Standard Care;|
| Other: Gelfoam Only<br>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<br>* 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.<br>* Other names: Gelfoam 100;Drug: Rescue treatment<br>* Thrombin-containing hemostats included in standard care at the site<br>* Other names: Standard Care;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | within 97 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical hemostasis, bleeding, fibrin sealant, fibrinogen, thrombin, spray dried