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

February 8, 2019 updated by: Terumo BCTbio

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Kumasi, Ghana
        • Komfo Anokye Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
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.
Days 0, 1, 2, 3, 7, 28
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.
Days 0, 1, 2, 3, 7, 28
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.
Days 0, 1, 2, 3, 7, 28
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.
Days 0, 1, 2, 3, 7, 28
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.
Days 0, 1, 2, 3, 7, 28
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.
Days 0, 1, 2, 3
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.
Days 0, 1, 2, 3
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.
Days 0, 1, 2, 3
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.
Days 0, 1, 2, 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo BCTbio

Investigators

  • Principal Investigator: Shirley Owusu-Ofori, MD, Komfo Anokye Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTS-5031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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