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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02118428 |
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Date of registration:
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27/02/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
AIMS |
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Scientific 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 |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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227 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02118428 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Shirley Owusu-Ofori, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Komfo Anokye Teaching Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Biological: Untreated Whole Blood
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Device: Mirasol-treated Whole Blood
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Primary Outcome(s)
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Percentage of Participants With Incidence of Transfusion-transmitted Malaria
[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)]
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Secondary Outcome(s)
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Hematology Parameter in Fresh Whole Blood Products - Platelet Count
[Time Frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)]
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Hematology Parameter in Patients - Hematocrit
[Time Frame: Days 0, 1, 2, 3, 7, 28]
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Hematology Parameter in Patients - Platelet Count
[Time Frame: Days 0, 1, 2, 3, 7, 28]
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Hematology Parameter in Patients - Red Blood Cell (RBC) Count
[Time Frame: Days 0, 1, 2, 3, 7, 28]
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Hematology Parameter in Patients - Total Hemoglobin
[Time Frame: Days 0, 1, 2, 3, 7, 28]
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Biochemistry Parameter in Patients - Potassium
[Time Frame: Days 0, 1, 2, 3]
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Coagulation Parameter in Patients - International Normalized Ratio (INR)
[Time Frame: Days 0, 1, 2, 3]
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Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit
[Time Frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)]
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Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count
[Time Frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)]
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Biochemistry Parameter in Fresh Whole Blood Products - Potassium
[Time Frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)]
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Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count
[Time Frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)]
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Coagulation Parameter in Patients - Prothrombin Time
[Time Frame: Days 0, 1, 2, 3]
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Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin
[Time Frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)]
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Hematology Parameter in Patients - White Blood Cell (WBC) Count
[Time Frame: Days 0, 1, 2, 3, 7, 28]
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Bacterial Contamination of Fresh Whole Blood (FWB) Products
[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]
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Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
[Time Frame: Days 0, 1, 2, 3]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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