Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00813904
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00813904
Study Brief:
Protocol Section:
NCT00813904