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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00223704
Eligibility Criteria:
Inclusion Criteria:
1. Subjects, 18 to 80 years of age, scheduled for elective CABG requiring CPB
2. For female subjects, the following conditions must be met:
postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and on every study day
Exclusion Criteria:
1. Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
2. Preoperative hematocrit less than 30%
3. Preoperative platelet count less than 100X109ml-1
4. GPIIb/IIIa antagonist within 48 hours of surgery
5. Emergency surgery
6. Impaired renal function (serum creatinine \>1.6 mg/dl)
7. Pregnancy
8. Breast-feeding
9. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
10. History of alcohol or drug abuse
11. Treatment with any investigational drug in the 1 month preceding the study
12. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
13. Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00223704
Study Brief:
Protocol Section:
NCT00223704