Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Completed · Phase 4
Conditions studied: Blood Loss, Surgical
In brief
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
Key facts
- Study ID
- NCT00813904
- Run by
- ZymoGenetics
- People needed
- 31
- Starts
- 2009-01-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2011-12-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tuscon Orthopaedic Institute — Tuscon, Arizona, United States
- Tuscon Orthopaedic Institute — Tuscon, Arizona, United States
Full record on ClinicalTrials.gov
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