Status:
COMPLETED
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Lead Sponsor:
ZymoGenetics
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
Detailed Description
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arte...
Eligibility Criteria
Inclusion
- Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
- Age of 18 years or older at time of consent
- Bleeding indicating treatment with rThrombin during the course of the surgical procedure
- Signed informed consent document approved by an institutional review board or independent ethics committee
Exclusion
- Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
- Known hypersensitivity to rThrombin product or any of its components
- Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
- Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
- Treatment with any experimental agent within 30 days of study enrollment or treatment
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00813904
Start Date
January 1 2009
End Date
July 1 2010
Last Update
December 8 2011
Active Locations (1)
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1
Tuscon Orthopaedic Institute
Tuscon, Arizona, United States, 85712