Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

• Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity [ Time Frame: Days 1 through 29, continuously ] [ Designated as safety issue: Yes ]
  An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment
  
  
• Number of Participants With AEs by Maximum Severity [ Time Frame: Days 1 through 29, continuously ] [ Designated as safety issue: Yes ]
  An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.
  
  
• Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts [ Time Frame: Baseline and Day 29 from Baseline ] [ Designated as safety issue: Yes ]
  Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8-10^9/L. Neutrophils: Grade 0=normal; Grade 1=<LLN-1.5x10^9/L; Grade 2=<1.5-1.0x10^9/L
  
  
• Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels [ Time Frame: Baseline and Day 29 from Baseline ] [ Designated as safety issue: Yes ]
  LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.
  
  
• Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels [ Time Frame: Baseline and Day 29 from Baseline ] [ Designated as safety issue: Yes ]
  ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.
  
  
• Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher [ Time Frame: Baseline and Day 29 from Baseline ] [ Designated as safety issue: Yes ]
  ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
  
  
• Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher [ Time Frame: Baseline and Day 29 from Baseline ] [ Designated as safety issue: No ]
  Grade 0=normal.
  
  

• Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody [ Time Frame: At Day 29 ] [ Designated as safety issue: No ]
  Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.
  
  

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 hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision. Limited data currently exist on the effects of rThrombin exposure in pediatric patients. This Phase 4 trial aims to provide additional information on the use of rThrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.