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

Terumo BCTbio227 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

227

Conditions

Malaria

Interventions

Mirasol-treated Whole BloodDEVICE

Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood

Untreated Whole BloodBIOLOGICAL

Transfusion with untreated fresh Whole Blood

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Outcomes

Primary Outcomes

Percentage of Participants With Incidence of Transfusion-transmitted Malaria

Percentage of Participants who contracted transfusion-transmitted malaria (TTM)

Time frame: Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)

Secondary Outcomes

Bacterial Contamination of Fresh Whole Blood (FWB) Products

Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject. Control products were only sampled post-collection, so no results for post-Mirasol treatment. All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment. All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture.

Time frame: immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion

Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit

Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.