MalariaAIMSNCT02118428
Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
A study testing Mirasol-treated Whole Blood and Untreated Whole Blood in people with Malaria, run by Terumo BCTbio at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- Mirasol-treated Whole Blood and Untreated Whole Blood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteGhana
- Study dates
- Mar 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.
- Conditions
- Malaria
- Being tested
- Mirasol-treated Whole Blood, Untreated Whole Blood
- Keywords
- whole blood, transfusion, Plasmodium, Malaria, Pathogen Reduction Technology, Whole blood transfusion
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirasol-treated Whole BloodDevice
Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
Untreated Whole BloodBiological
Transfusion with untreated fresh Whole Blood
| Study group | Role | What they receive |
|---|---|---|
| Mirasol | Experimental | Transfusions with Mirasol-treated whole blood Receives: Device: Mirasol-treated Whole Blood |
| Control | Active comparator | Transfusions with untreated whole blood Receives: Biological: Untreated Whole Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Incidence of Transfusion-transmitted Malaria
Percentage of Participants who contracted transfusion-transmitted malaria (TTM)
Measured: 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 outcomes (16)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
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.
Measured: Days 0, 1, 2, 3, 7, 28
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.
Measured: Days 0, 1, 2, 3, 7, 28
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.
Measured: Days 0, 1, 2, 3, 7, 28
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.
Measured: Days 0, 1, 2, 3, 7, 28
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.
Measured: Days 0, 1, 2, 3, 7, 28
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.
Measured: Days 0, 1, 2, 3
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.
Measured: Days 0, 1, 2, 3
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.
Measured: Days 0, 1, 2, 3
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.
Measured: Days 0, 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCTbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shirley Owusu-Ofori, MD, Principal investigator, Komfo Anokye Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118428
- Sponsor's protocol ID
- CTS-5031
- Acronym
- AIMS
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2014
- Last updated
- 10 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27116282
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02118428
- Acronym / sponsor ID
- AIMS / CTS-5031
- Conditions
- Malaria
- Keywords
- whole blood, transfusion, Plasmodium, Malaria, Pathogen Reduction Technology, Whole blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Terumo BCTbioIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirasol | Experimental | Device: Mirasol-treated Whole BloodTransfusions with Mirasol-treated whole blood |
| Control | Active comparator | Biological: Untreated Whole BloodTransfusions with untreated whole blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirasol-treated Whole BloodTransfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood | Device | Mirasol |
| Untreated Whole BloodTransfusion with untreated fresh Whole Blood | Biological | Control |
Primary outcome
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)
16 secondary outcomes
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
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)
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)
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)
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)
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)
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)
Hematology Parameter in Patients - Hematocrit
Time frame: Days 0, 1, 2, 3, 7, 28
Hematology Parameter in Patients - Total Hemoglobin
Time frame: Days 0, 1, 2, 3, 7, 28
Hematology Parameter in Patients - Platelet Count
Time frame: 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
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Time frame: Days 0, 1, 2, 3, 7, 28
Biochemistry Parameter in Patients - Potassium
Time frame: Days 0, 1, 2, 3
Coagulation Parameter in Patients - Prothrombin Time
Time frame: Days 0, 1, 2, 3
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Time frame: Days 0, 1, 2, 3
Coagulation Parameter in Patients - International Normalized Ratio (INR)
Time frame: Days 0, 1, 2, 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27116282Allain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Owusu-Ofori, MD principal investigator
Komfo Anokye Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirasol-treated Whole Blood and Untreated Whole Blood in people with Malaria, run by Terumo BCTbio at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.