Back to resultsClinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria (AIMS)
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Mirasol-treated Whole Blood
Untreated Whole Blood
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring whole blood, transfusion, Plasmodium, Malaria, Pathogen Reduction Technology, Whole blood transfusion
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
Sites / Locations
- Komfo Anokye Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mirasol
Control
Arm Description
Transfusions with Mirasol-treated whole blood
Transfusions with untreated whole blood
Outcomes
Primary Outcome Measures
Percentage of Participants With Incidence of Transfusion-transmitted Malaria
Percentage of Participants who contracted transfusion-transmitted malaria (TTM)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02118428
Brief Title
Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
Acronym
AIMS
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terumo BCTbio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
whole blood, transfusion, Plasmodium, Malaria, Pathogen Reduction Technology, Whole blood transfusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirasol
Arm Type
Experimental
Arm Description
Transfusions with Mirasol-treated whole blood
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Transfusions with untreated whole blood
Intervention Type
Device
Intervention Name(s)
Mirasol-treated Whole Blood
Intervention Description
Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
Intervention Type
Biological
Intervention Name(s)
Untreated Whole Blood
Intervention Description
Transfusion with untreated fresh Whole Blood
Primary Outcome Measure Information:
Title
Percentage of Participants With Incidence of Transfusion-transmitted Malaria
Description
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 Outcome Measure Information:
Title
Bacterial Contamination of Fresh Whole Blood (FWB) Products
Description
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
Title
Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit
Description
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.
Time Frame
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Title
Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin
Description
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.
Time Frame
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Title
Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count
Description
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.
Time Frame
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Title
Hematology Parameter in Fresh Whole Blood Products - Platelet Count
Description
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.
Time Frame
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Title
Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count
Description
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.
Time Frame
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Title
Biochemistry Parameter in Fresh Whole Blood Products - Potassium
Description
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.
Time Frame
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Title
Hematology Parameter in Patients - Hematocrit
Description
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.
Time Frame
Days 0, 1, 2, 3, 7, 28
Title
Hematology Parameter in Patients - Total Hemoglobin
Description
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.
Time Frame
Days 0, 1, 2, 3, 7, 28
Title
Hematology Parameter in Patients - Platelet Count
Description
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.
Time Frame
Days 0, 1, 2, 3, 7, 28
Title
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Description
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.
Time Frame
Days 0, 1, 2, 3, 7, 28
Title
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Description
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.
Time Frame
Days 0, 1, 2, 3, 7, 28
Title
Biochemistry Parameter in Patients - Potassium
Description
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.
Time Frame
Days 0, 1, 2, 3
Title
Coagulation Parameter in Patients - Prothrombin Time
Description
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.
Time Frame
Days 0, 1, 2, 3
Title
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Description
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.
Time Frame
Days 0, 1, 2, 3
Title
Coagulation Parameter in Patients - International Normalized Ratio (INR)
Description
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.
Time Frame
Days 0, 1, 2, 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Owusu-Ofori, MD
Organizational Affiliation
Komfo Anokye Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Komfo Anokye Teaching Hospital
City
Kumasi
Country
Ghana
12. IPD Sharing Statement
Citations:
PubMed Identifier
27116282
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.
Results Reference
derived
Learn more about this trial
Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
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