Phase 4
N=30
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
Blood Loss, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT00859547 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Dec 2011
Primary outcome: Primary: Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity — 0; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rThrombin, 1000 IU/mL (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- ZymoGenetics
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity |
0; 1; 0; 0; 3 | — |
| PRIMARY Number of Participants With AEs by Maximum Severity |
3; 3; 0; 3; 1; 5 | — |
| PRIMARY Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts |
30; 25; 30; 26; 28; 25 | — |
| PRIMARY Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels |
13; 7; 4; 5; 1; 0 | — |
| PRIMARY Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels |
30; 25; 0; 1 | — |
| PRIMARY Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher |
22; 19; 7; 5 | — |
| PRIMARY Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher |
28; 24 | — |
| SECONDARY Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody |
— | — |
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 pediatric patients, newborn through 17 years of age.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00859547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.