Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria

AIMS Study: African Investigation of Mirasol System for Whole Blood. Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria

The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.

Inclusion Criteria:

• Age ≥ 18 years
• Patient is blood group O+
• Anticipated to be hospitalized for at least 3 consecutive days after initial study transfusion
• Expected to require no more than 2 units of Fresh Whole Blood in the 3 days following randomization
• Agree to return to the hospital for the follow-up visits
• Women of Child Bearing Potential must have a negative pregnancy test within 72 hours before randomization when warranted and must agree to practice a medically acceptable contraception regimen or agree to abstain from heterosexual intercourse during their study participation.
• Patient or legally authorized representative has given written informed consent

Exclusion Criteria:

• Symptoms of clinical malaria (confirmed by microscopy)
• Patient has received antimalarial treatment within 7 days prior to randomization
• Fever (Central body temperature greater than 38.5°C)
• Massive bleeding expected to require more than two Fresh Whole Blood units within 3 days from randomization
• Transfusion(s) of a blood product within 1 month prior to randomization
• Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment
• Previous treatment with other pathogen-reduced blood products
• Females who are pregnant