Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cerus Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Age at least 18 years, of either gender
Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and RBC distribution width(RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), creatinine). Values outside of normal reference range thought not to be clinically significant may be allowed with a protocol exception.
Minimum hemoglobin levels of 13 g/dL for female and 14.5 g/dL for male subjects
Negative blood donor screening test panel for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), human T cell leukemic virus (HTLV), Syphilis, and west nile virus (WNV) (if available)
Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
Meet or exceed American Association of Blood Banks (AABB) guidelines for blood donation (with the exception of travel deferrals).
Signed and dated informed consent form
You may not be if
• Clinically significant acute or chronic disease (as determined by the Investigator)
* History of RBC autoantibodies/autoimmune hemolytic anemia, RBC allo-antibodies, or autoimmune disease
* History of congenital red cell disorders including glucose 6 phosphate dehydrogenase (G-6PD) deficiency
* Serum ferritin \<12 ng/mL
* Positive direct antiglobulin test (DAT) or indirect antiglobulin test (IAT) at study entry
* Immunosuppressive therapy (e.g., oral or Intravenous (IV) prednisone) within the past 28 days
* Treatment with any medication known to affect RBC viability
* Pregnant or nursing female
* Male subjects or female subjects of childbearing potential not using effective contraception
* Participation in another clinical study currently or within the past 28 days
* Prior exposure to S 303 treated RBCs
* Pre-existing antibody specific to S 303 treated RBCs
Clareo Health | A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells
