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Completed

NCT Number: NCT00859547

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

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.

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Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona Burn Center

Phoenix, Arizona, 85008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rThrombin, 1000 IU/mL

Biological

rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.

Other names: RECOTHROM

Primary outcomes

  1. 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

    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

  2. Number of Participants With AEs by Maximum Severity

    Time frame: Days 1 through 29, continuously

    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.

  3. 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

    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

  4. Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels

    Time frame: Baseline and Day 29 from Baseline

    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.

  5. Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels

    Time frame: Baseline and Day 29 from Baseline

    ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.

  6. 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

    ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.

  7. 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

    Grade 0=normal.

Secondary outcomes

  1. Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody

    Time frame: At Day 29

    Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.

Sponsors and collaborators

Lead sponsor

ZymoGenetics

Industry

Registry information

Official study title

A Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 11, 2009
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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