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

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

Official Title
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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

Conditions
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Malaria

Intervention / Treatment
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* Device: Mirasol-treated Whole Blood
* Biological: Untreated Whole Blood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirasol<br>Transfusions with Mirasol-treated whole blood | Device: Mirasol-treated Whole Blood<br>* Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood<br>|
| Active Comparator: Control<br>Transfusions with untreated whole blood | Biological: Untreated Whole Blood<br>* Transfusion with untreated fresh Whole Blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Incidence of Transfusion-transmitted Malaria | Percentage of Participants who contracted transfusion-transmitted malaria (TTM) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | 
| Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | 
| Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | 
| Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | 
| Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | 
| Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | 
| Hematology Parameter in Patients - Hematocrit | Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 | 
| Hematology Parameter in Patients - Total Hemoglobin | Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 | 
| Hematology Parameter in Patients - Platelet Count | Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 | 
| Hematology Parameter in Patients - Red Blood Cell (RBC) Count | RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 | 
| Hematology Parameter in Patients - White Blood Cell (WBC) Count | WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 | 
| Biochemistry Parameter in Patients - Potassium | Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 | 
| Coagulation Parameter in Patients - Prothrombin Time | Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 | 
| Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 | 
| Coagulation Parameter in Patients - International Normalized Ratio (INR) | INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole blood, transfusion, Plasmodium, Malaria, Pathogen Reduction Technology, Whole blood transfusion