Clinical trial NCT02118428: Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: whole blood
transfusion
Plasmodium
Malaria
Pathogen Reduction Technology
Whole blood transfusion
Lead sponsor: Terumo BCTbio
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Incidence of Transfusion-transmitted Malaria
timeFrame: 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:
measure: Bacterial Contamination of Fresh Whole Blood (FWB) Products
timeFrame: 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
measure: Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit
timeFrame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
measure: Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin
timeFrame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
measure: Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count
timeFrame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
measure: Hematology Parameter in Fresh Whole Blood Products - Platelet Count
timeFrame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
measure: Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count
timeFrame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
measure: Biochemistry Parameter in Fresh Whole Blood Products - Potassium
timeFrame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
measure: Hematology Parameter in Patients - Hematocrit
timeFrame: Days 0, 1, 2, 3, 7, 28
measure: Hematology Parameter in Patients - Total Hemoglobin
timeFrame: Days 0, 1, 2, 3, 7, 28
measure: Hematology Parameter in Patients - Platelet Count
timeFrame: Days 0, 1, 2, 3, 7, 28
measure: Hematology Parameter in Patients - Red Blood Cell (RBC) Count
timeFrame: Days 0, 1, 2, 3, 7, 28
measure: Hematology Parameter in Patients - White Blood Cell (WBC) Count
timeFrame: Days 0, 1, 2, 3, 7, 28
measure: Biochemistry Parameter in Patients - Potassium
timeFrame: Days 0, 1, 2, 3
measure: Coagulation Parameter in Patients - Prothrombin Time
timeFrame: Days 0, 1, 2, 3
measure: Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
timeFrame: Days 0, 1, 2, 3
measure: Coagulation Parameter in Patients - International Normalized Ratio (INR)
timeFrame: Days 0, 1, 2, 3
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
Study officials:
affiliation: Komfo Anokye Teaching Hospital
name: Shirley Owusu-Ofori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S. Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial. Lancet. 2016 Apr 23;387(10029):1753-61. doi: 10.1016/S0140-6736(16)00581-X.