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

Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118428
• Other study ID #: CTS-5031
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2019
• Source: Terumo BCTbio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

Device:
• Mirasol-treated Whole Blood
Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood

Biological:
• Untreated Whole Blood
Transfusion with untreated fresh Whole Blood

Locations

Country	Name	City	State
Ghana	Komfo Anokye Teaching Hospital	Kumasi

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCTbio

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Incidence of Transfusion-transmitted Malaria	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	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.	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
Secondary	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.	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Secondary	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.	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Secondary	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.	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Secondary	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.	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Secondary	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.	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Secondary	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.	Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Secondary	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.	Days 0, 1, 2, 3, 7, 28
Secondary	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.	Days 0, 1, 2, 3, 7, 28
Secondary	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.	Days 0, 1, 2, 3, 7, 28
Secondary	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.	Days 0, 1, 2, 3, 7, 28
Secondary	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.	Days 0, 1, 2, 3, 7, 28
Secondary	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.	Days 0, 1, 2, 3
Secondary	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.	Days 0, 1, 2, 3
Secondary	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.	Days 0, 1, 2, 3
Secondary	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.	Days 0, 1, 2, 3