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Completed

NCT Number: NCT02118428

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

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

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirasol-treated Whole Blood

Device

Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood

Untreated Whole Blood

Biological

Transfusion with untreated fresh Whole Blood

Primary outcomes

  1. 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)

    Percentage of Participants who contracted transfusion-transmitted malaria (TTM)

Secondary outcomes

  1. 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

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

  8. Hematology Parameter in Patients - Hematocrit

    Time frame: 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.

  9. Hematology Parameter in Patients - Total Hemoglobin

    Time frame: 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.

  10. Hematology Parameter in Patients - Platelet Count

    Time frame: 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.

  11. Hematology Parameter in Patients - Red Blood Cell (RBC) Count

    Time frame: 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.

  12. Hematology Parameter in Patients - White Blood Cell (WBC) Count

    Time frame: 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.

  13. Biochemistry Parameter in Patients - Potassium

    Time frame: 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.

  14. Coagulation Parameter in Patients - Prothrombin Time

    Time frame: 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.

  15. Coagulation Parameter in Patients - Activated Partial Thromboplastin Time

    Time frame: 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.

  16. Coagulation Parameter in Patients - International Normalized Ratio (INR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Terumo BCTbio

Industry

Registry information

Official study 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

Acronym: AIMS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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