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

Terumo

Status

Completed

Conditions

Malaria

Treatments

Biological: Untreated Whole Blood

Device: Mirasol-treated Whole Blood

Study type

Interventional

Funder types

Industry

Identifiers

NCT02118428

CTS-5031

Details and patient eligibility

About

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

Enrollment

227 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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