Trial record 2 of 2 for:    profibrix

Safety and Efficacy Study of Fibrocaps to Treat Surgical Bleeding in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Mallinckrodt
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT02117349
First received: April 14, 2014
Last updated: August 6, 2015
Last verified: August 2015
  Purpose
The purpose of the study is to show that Fibrocaps plus gelatin sponge is better than gelatin sponge alone in stopping mild to moderate bleeding in children having surgery

Condition Intervention Phase
Surgical Bleeding
Drug: Fibrocaps plus gelatin sponge
Drug: Gelatin Sponge
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ (Raplixa™) in Intraoperative Surgical Hemostasis in a Pediatric Population

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Time to Hemostasis (TTH) [ Time Frame: within 4 minutes of study drug initiation ] [ Designated as safety issue: No ]
    Assessment of Time to Hemostasis within 4 minutes of Study Medication application.


Secondary Outcome Measures:
  • Time to Hemostasis within 5 minutes [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Assessment of Time to Hemostasis within 5 minutes of Study Medication application.

  • Secondary - Safety [ Time Frame: Visit 1 (Day -30) through Visit 7 (D90+/- 7 days) ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 108
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrocaps plus Gelatin sponge
During surgery subjects randomized to this arm will be treated with Fibrocaps and a gelatin sponge.
Drug: Fibrocaps plus gelatin sponge
During the surgical procedure on Day 1 (Visit 2), subjects will be initially treated with Fibrocaps plus gelatin sponge at the target bleeding site and the time to stop bleeding will be assessed. Subjects may be retreated with Fibrocaps and gelatin sponge treatment as necessary during the 5-minute assessment period.
Other Names:
  • Raplixa
  • Gelfoam
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

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  • Vascular Surgery
  • Hepatic resection
  • Soft tissue dissection

Inclusion Criteria (pre-surgery):

  1. Age is 0 days through < 18 years of age at time of randomization
  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 at 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. Mild or moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
  8. Approximate Target Bleeding Sites surface area of ≤ 100 cm2
  9. No prior use of a topical hemostat containing thrombin during prior surgeries
  10. Has not received any blood transfusions between screening and study treatment
  11. 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 2 years 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)
  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
  6. Platelets < 100 x10ᴧ9 PLT/L during screening
  7. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
  8. Known hypersensitivity to Fibrocaps or any of its components
  9. Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
  10. Known allergy to porcine gelatin
  11. Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact subject safety or compliance with study procedures
  12. Subject is currently participating or has participated in another clinical study involving an investigational agent within 30 days of the planned date of surgery
  13. Subject is planning to participate in another clinical trial within the 90-day follow-up period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02117349

Contacts
Contact: Consuelo Blosch, MD 206-262-4002 consuelo.blosch@themedco.com
Contact: Beth Sleicher 206-262-4010 beth.sleicher@themedco.com

Locations
United States, Arizona
Arizona Burn Center Recruiting
Phoenix, Arizona, United States, 85008
United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Shriner's Hospital for Children Northern California Recruiting
Sacramento, California, United States, 95817
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
United States, Missouri
St. Louis Children's Hospital Washington University Recruiting
St. Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest University School of Medicine Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
SGM Physician Research Consortium Recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Consuelo Blosch, MD ProFibrix Inc. a wholly owned subsidiary of The Medcines Company
Principal Investigator: Kevin Foster, MD,MBA,FACS The Arizona Burn Center
  More Information

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02117349     History of Changes
Other Study ID Numbers: FC-007 
Study First Received: April 14, 2014
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2016