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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00425334
Eligibility Criteria:
Inclusion Criteria:
* Adult male ASA class I or II patients over the age of 18 scheduled for elective total prostatectomy surgery with anticipated blood loss greater than 500 mL
* Patients must be in good health (other than the indication for prostatectomy surgery) as determined by medical history, physical examination, clinical laboratory studies and electrocardiogram (ECG)
* At screening (within 2 weeks of the scheduled surgery) the blood chemistry and hematology (Hb, Hct, RBC, WBC, platelets, PT, PTT, plasma fibrinogen, fibrin split products and haptoglobin) must be within the laboratory normal limits
* Patients must test negative for HIV and hepatitis screens
* Patients must sign an Informed Consent Form (see Appendix II) for the study, which has been reviewed and approved by the Institutional Review Board, prior to screening and entry into the study
* Patients must be available within the continental United States for the period of this study, and willing to complete the follow-up at 4-6 weeks
* Patients must be able to understand and read English
Exclusion Criteria:
* Any acute or chronic condition which would limit the patient's ability to complete the study or jeopardize the safety of the patient
* History or clinical manifestations of a significant cardiovascular or pulmonary disorder
* Clinically significant psychiatric disorder requiring active treatment
* History of diabetes requiring active treatment
* History or clinical manifestation of significant renal or hepatic disorder
* History of thyroid disease or clinical symptoms consistent with thyroid disease
* History of bleeding disorder
* History or family history of a hemoglobinopathy
* Patients with contraindications to TEE probe insertion
* Patients who have received any other investigational drugs within 30 days prior to administration of the study drug
* Professional or ancillary personnel involved with this study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00425334
Study Brief:
Protocol Section:
NCT00425334