Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201406000777310 Date of Approval: 27/02/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AIMS: African Investigation of Mirasol System for Whole Blood
Official scientific title Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
Brief summary describing the background and objectives of the trial The Mirasol system for Whole Blood is intended to reduce the load of Plasmodium spp. and inactivate residual white blood cells in donor whole blood intended for transfusion. This trial will evaluate the efficacy of Mirasol-treated Fresh Whole Blood to prevent malaria transmission by transfusion.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AIMS
Disease(s) or condition(s) being studied Haematological Disorders,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 12/03/2014
Actual trial start date 12/03/2014
Anticipated date of last follow up 01/08/2014
Actual Last follow-up date 01/12/2014
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 226
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
CTS-5031 Committee on Human Research Publication and Ethics, Kumasi/ CHRPE/AP/200/13
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization (4) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mirasol-treated whole blood transfusion maximum 2 study transfusions not applicable Mirasol-treated whole blood 125
Control Group untreated whole blood transfusion maximum 2 study transfusions not applicable untreated whole blood 125 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age equal to or more than 18 years. Blood group O+. Hospitalized for at least 3 consecutive days after initial study transfusion. Require no more than 2 units of whole blood in the 3 days following randomization. Agree to return to the hospital for follow-up visits. Women of child bearing potential must have negative pregnancy test within 72 hours before randomization and must agree to practice a contraception regimen or agree to abstain from heterosexual intercourse during their study participation. Patient or legally authorized representative has given written informed consent. Symptoms of clinical malaria. Anti-malarial treatment within 7 days prior to randomization. Fever greater than 38.5°C. Massive bleeding expected to require more than 2 whole blood units within 3 days from randomization. Transfusion 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 pregant. 18 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/08/2013 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
University Post Office Kumasi Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of transfusion-transmitted malaria Day 1 post-initial transfusion Day 3 post-initial transfusion Day 7 post-initial transfusion Day 28 post-initial transfusion
Secondary Outcome Bacterial contamination of whole blood products Pre-Mirasol treatment Post-Mirasol treatment
Secondary Outcome Transmission rates in subpopulation of prior non-parasitemic subjects receiving parasitemic products Day 1 post-transfusion Day 3 post-transfusion Day 7 post-transfusion Day 28 post-transfusion
Secondary Outcome Transfusion reactions and treatment-emergent adverse events. Continuously during 28 days post-initial transfusion.
Secondary Outcome Hematological, biochemistry and coagulation parameters in whole blood products and patients Pre-and post-Mirasol Day 1 post-initial transfusion Day 2 post-initial transfusion Day 3 post-initial transfusion Day 7 post-initial transfusion Day 28 post-initial transfusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital PO Box 1934 Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Terumo BCT 10810 West Collins Avenue Lakewood, Denver 80215 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Terumo BCT Europe N.V. Ikaroslaan 41 Zaventem 1930 Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University of Cambridge Long Road Cambridge CB2 2PT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shirley Owusu-Ofori sowusu-ofori@kathhsp.org +233 20 817 8099 PO Box 1934
City Postal code Country Position/Affiliation
Kumasi Ghana Head Transfusion Medicine Unit
Role Name Email Phone Street address
Public Enquiries Liesbeth Deberdt liesbeth.deberdt@terumobct.com +32 2 715 05 39 Ikaroslaan 41
City Postal code Country Position/Affiliation
Zaventem 1930 Belgium Clinical Project Leader/Terumo BCT
Role Name Email Phone Street address
Scientific Enquiries Liesbeth Deberdt liesbeth.deberdt@terumobct.com +32 2 715 05 39 Ikaroslaan 41
City Postal code Country Position/Affiliation
Zaventem 1930 Belgium Clinical Project Leader / Terumo BCT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information