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

Not Applicable

Completed

Conditions: Malaria

Interventions: Biological: Untreated Whole Blood
Device: Mirasol-treated Whole Blood

Registration Number: NCT02118428

Lead Sponsor: Terumo BCTbio

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 227

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Untreated Whole Blood	Transfusions with untreated whole blood
Mirasol	Mirasol-treated Whole Blood	Transfusions with Mirasol-treated whole blood

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Incidence of Transfusion-transmitted Malaria	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)	Percentage of Participants who contracted transfusion-transmitted malaria (TTM)

Secondary Outcome Measures

Name	Time	Method
Bacterial Contamination of Fresh Whole Blood (FWB) Products	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	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.
Hematology Parameter in Patients - White Blood Cell (WBC) Count	Days 0, 1, 2, 3, 7, 28	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.
Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)	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.
Hematology Parameter in Patients - Hematocrit	Days 0, 1, 2, 3, 7, 28	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.
Coagulation Parameter in Patients - Prothrombin Time	Days 0, 1, 2, 3	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.
Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)	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.
Hematology Parameter in Fresh Whole Blood Products - Platelet Count	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)	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.
Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)	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.
Hematology Parameter in Patients - Red Blood Cell (RBC) Count	Days 0, 1, 2, 3, 7, 28	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.
Biochemistry Parameter in Patients - Potassium	Days 0, 1, 2, 3	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.
Coagulation Parameter in Patients - International Normalized Ratio (INR)	Days 0, 1, 2, 3	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.
Hematology Parameter in Patients - Platelet Count	Days 0, 1, 2, 3, 7, 28	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.
Hematology Parameter in Patients - Total Hemoglobin	Days 0, 1, 2, 3, 7, 28	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.
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time	Days 0, 1, 2, 3	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.
Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)	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.
Biochemistry Parameter in Fresh Whole Blood Products - Potassium	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)	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.