INTERCEPT Safety Evaluation in Anemic Patients

Exclusion criteria

• ✕. Patients must be18 years of age or older;
• ✕. Patients must have a hemoglobin level of \>/= 5.0 g/dl. Patients with hemoglobin levels of \>7.0 will not be excluded provided the patient's physician deems transfusion is needed to address anemia-induced symptoms.
• ✕. Patients must sign informed consent prior to initiation of any study-specific procedure / treatment. Enrolled patients may give additional consent for specimens collected during this study to be used for future research on TTI. Patients may participate in the main trial and decline collection of specimens for future research on TTI.
• ✕. Patients must agree to be hospitalized for a maximum of 72 hours after initiation of a study transfusion;
• ✕. Female patients of childbearing potential must:
• ✕. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and
• ✕. use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. These include combined oral contraceptives, implants, injectable, some intrauterine devices, sexual abstinence or vasectomized partner. The selected method must be used for the duration of study participation that means from day 1 (day of initiation of study transfusion) until day 58 (Final Study Visit).
• ✕. Patients with blood group AB (due to concern of limited supply).