Status:
COMPLETED
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
Lead Sponsor:
ZymoGenetics
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief Summary
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatri...
Detailed Description
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in 5 Phase 2 studies, 1 pivotal Phase 3 study, and 1 Phase 3b study, in surgical indications such as: spinal surgery, major he...
Eligibility Criteria
Inclusion
- Age of newborn through 17 years at time of enrollment
- At least 1 skin graft recipient site measuring at least 1% of total body surface area (TBSA)
- Total initial burn wounds estimated to measure less than 40% of TBSA
- Bleeding indicating treatment with rThrombin during the surgical procedure
- Females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment
- informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (IRB/IEC)
- Participant has signed an IRB/IEC-approved pediatric assent document, if applicable
Exclusion
- Gestational age younger than 36 weeks at birth (for infants younger than 2 years)
- Documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded)
- Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury
- Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies
- Presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors
- Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed)
- History of HIV infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications
- Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures
- Breastfeeding or being breastfed
- Treatment with any experimental agent within 30 days of study enrollment or treatment
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00859547
Start Date
March 1 2009
End Date
January 1 2010
Last Update
January 26 2012
Active Locations (1)
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1
Arizona Burn Center
Phoenix, Arizona, United States, 85008