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:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00618358
Eligibility Criteria:
Preoperative Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for participation in the study:
* \> 18 years of age
* Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass and primary and secondary arteriovenous access procedures
* Subject is willing and able to comply with all aspects of the treatment and evaluation schedule
* Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site
Preoperative Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:
* Subject has a known local or systemic infection
* Subjects with known coagulapathies including hemophilia, factor deficiencies, platelet count \< 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR \> 1.5
* Subject is participating in a clinical trial that requires treatment with another investigational device or drug
* Subject is lactating or pregnant, or does not agree to use contraception for the duration of the study
* Subject has a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin
* The investigator determines that the subject should not be included in the study for reason(s) not already specified
Intraoperative Inclusion Criteria: Subjects must meet the following intraoperative inclusion criteria to be eligible for randomization:
• Suture line leaks (bleeding) confirmed prior to randomization.
Intraoperative Exclusion Criteria: Subjects who meet any of the following intraoperative exclusion criteria are considered screening failures and are not eligible to be randomized:
* Incidental finding of any of the preoperative exclusion criteria
* Subject has obvious contamination or a concurrent systemic infection
* Investigator determines that participation in the study may jeopardize the safety or welfare of the subject
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00618358
Study Brief:
Protocol Section:
NCT00618358