Anemie
Conditions
Interventions
Phase I: biotinylated RBCs stored for 35 days. 
Phase II: biotinylated RBCs stored for 42 days.
Sponsors
Terumo
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for participant selection: 1. Healthy volunteers 2. Age >= 18 years < 60 years 3. Normal health status as per Sanquin National Blood Bank criteria for healthy donors 4. Able to commit to the study schedule 5. Participants of childbearing potential must agree to use a medically acceptable method of contraception throughout of the study 6. Participants of childbearing potential must be willing to take a pregnancy test prior to WB donation 7. Signed and dated informed consent form within 30 days of the Day 0 visit
Exclusion criteria
Exclusion criteria: Exclusion criteria for participant selection: 1. Pregnant or nursing females 2. Serum ferritin <12 ng/mL 3. Has previously completed this study with evaluable data points 4. Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g. pharmaceutical) 5. Participants who are deferred from volunteer community donations as per Sanquin National Blood Bank criteria for healthy donors 6. As determined by the Investigator a. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (e.g. G6PD deficiency). b. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies c. Clinically significant acute or chronic disease d. Reported history or known hypersensitivity to biotin and iodine e. Treatment with any medication as specified in site deferral list f. Current drug use g. Currently abusing alcohol. Alcohol abuse is defined for men, consuming more than 4 drinks on any day or more than 14 drinks per week and for women, consuming more than 3 drinks on any day or more than 7 drinks per week 7. Previously transfused with RBCs within the last 120 days 8. A positive biotin antibody test if they have received any biotin labeled blood products in the past 9. Blood loss of more than 500 mL < 3 months, including blood donation 10. Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the RBCs derived from WB and processed with the Reveos system using the non-DEHP disposable sets meet the US criteria for 24-hour recovery after 42 days of storage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: To ensure RBCs derived from WB and processed with the Reveos system using the non-DEHP disposable set meet the European Directorate for the Quality of Medicines; Health Care (EDQM) criteria for a transfusable RBC product. | — |
Countries
Netherlands
Outcome results
None listed