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

NCT ID: NCT00859547

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-01-31

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 pediatric patients, newborn through 17 years of age.

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 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.

Conditions

Blood Loss, Surgical

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recombinant thrombin (rThrombin), 1000 IU/mL

Group Type: EXPERIMENTAL

rThrombin, 1000 IU/mL

Intervention Type: BIOLOGICAL

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

Interventions

rThrombin, 1000 IU/mL

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

Intervention Type: BIOLOGICAL

Other Intervention Names

RECOTHROM

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZymoGenetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Foster, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Burn Center

Locations

Arizona Burn Center

Phoenix, Arizona, United States

Countries

United States

References

Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.

Reference Type: DERIVED

PMID: 38837237 (View on PubMed)

Foster KN, Mullins RF, Greenhalgh DG, Gamelli RL, Glat P, Lentz CW, Kahn SA, Brandigi C, Fredlund P, Alexander WA. Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision. J Pediatr Surg. 2011 Oct;46(10):1992-9. doi: 10.1016/j.jpedsurg.2011.05.022.

Reference Type: DERIVED

PMID: 22008340 (View on PubMed)

Other Identifiers

499H01

Identifier Type: -

Identifier Source: org_study_id