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Safety and Efficacy Study of Raplixa™ (Fibrin Sealant [Human]) to Treat Surgical Bleeding in Children

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ClinicalTrials.gov Identifier: NCT02117349
Recruitment Status : Active, not recruiting
First Posted : April 17, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
The purpose of the study is to show that Raplixa plus gelatin sponge is better than gelatin sponge alone in stopping mild to moderate bleeding in children having surgery

Condition or disease Intervention/treatment Phase
Surgical Bleeding Drug: Raplixa plus Gelatin Sponge Drug: Gelatin Sponge Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 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
Study Start Date : December 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Raplixa plus gelatin sponge
During surgery subjects randomized to this arm will be treated with Raplixa and a gelatin sponge.
Drug: Raplixa plus Gelatin Sponge
During the surgical procedure on Day 1 (Visit 2), subjects will be initially treated with Raplixa plus gelatin sponge at the target bleeding site and the time to stop bleeding will be assessed. Subjects may be retreated with Raplixa and gelatin sponge treatment as necessary during the 5-minute assessment period.
Other Name: Fibrin Sealant [Human]

Gelatin sponge alone
During surgery subjects randomized to this arm will be treated with only gelatin sponge.
Drug: Gelatin Sponge
During the surgical procedure on Day 1 (Visit 2), subjects will be initially treated with a gelatin sponge alone at the target bleeding site and the time to stop bleeding will be assessed. Subjects may be retreated with gelatin sponge during the 5-minute time to stop bleeding assessment period.
Other Name: Gelfoam




Primary Outcome Measures :
  1. Time to Hemostasis (TTH) [ Time Frame: within 4 minutes of study drug initiation ]
    Assessment of Time to Hemostasis within 4 minutes of Study Medication application.


Secondary Outcome Measures :
  1. Time to Hemostasis within 5 minutes [ Time Frame: 5 minutes ]
    Assessment of Time to Hemostasis within 5 minutes of Study Medication application.

  2. Secondary - Safety [ Time Frame: Visit 1 (Day -30) through Visit 7 (D90+/- 7 days) ]
    Overall safety, as determined by the incidence, severity and relationship of adverse events (AEs), clinical laboratory abnormalities, estimated rates of immunogenicity and post-surgery bleeding complications



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

The study will enroll subjects undergoing one of the following surgical procedures:

  • Vascular Surgery
  • Hepatic surgery
  • Soft tissue surgery
  • Renal surgery
  • Spinal surgery

Inclusion Criteria (pre-surgery):

  1. Age is ≥36 weeks gestational age at birth (for infants) through <18 years of age at time of treatment
  2. Subject's legal representative (parent or guardian) has signed an institutional review board (IRB)-approved informed consent document
  3. If a subject is ≥ 7 years old, or appropriate age as defined by local regulations, the subject may be required to have signed an IRB-approved assent document
  4. Subject is scheduled to undergo one of the surgical procedures described above
  5. If female and of child-bearing potential, subject has negative pregnancy test on the day of surgery (baseline)
  6. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all of the follow-up study visits.

    Inclusion Criteria (during surgery):

  7. Presence of mild or moderate bleeding/oozing
  8. Target Bleeding Sites surface area of ≤100 cm2
  9. 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
  10. 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:

  1. Gestational age of <36 weeks at birth (for infants less than 6 months of age)
  2. Any clinically-significant congenital coagulation disorder (e.g., hemophilia A or B) that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator
  3. Baseline abnormalities of international normalized ratio (INR) > 2.5 or activated partial thromboplastin time (aPTT) > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin) or chronic disease state necessitating surgery (e.g., end stage liver disease).
  4. Aspartate Aminotransferase (ASAT/AST) and Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver disease where there is no upper limit for these analytes due to nature of their disease
  5. Subject is unwilling to receive blood products or products derived from human blood
  6. Platelets < 100 x10ᴧ9 PLT/L during screening unless due to chronic disease state, e.g., liver disease/failure, necessitating surgery
  7. Subject has known antibodies or hypersensitivity to Raplixa or any of it's components, other thrombin preparations or coagulation factors
  8. Known allergy to porcine gelatin
  9. Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact subject safety or compliance with study procedures
  10. Subject is; 1) currently participating in another clinical study or 2) has participated in another clinical study within 30 days of screening or 3) plans to participate in a clinical study prior to completion of the 30-day follow-up period

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
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

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02117349     History of Changes
Other Study ID Numbers: FC-007
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Mallinckrodt:
surgical hemostasis
bleeding
fibrin sealant
fibrinogen
thrombin
spray dried

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants