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.: PACTR202302787440132 Date of Approval: 06/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Mortality and Frequency of Red Blood Cell Allo-immunization in Recipients of Leukoreduced and Non-leukoreduced Whole Blood Transfusion in Uganda
Official scientific title Comparison of Mortality and Frequency of Red Blood Cell Allo-immunization in Recipients of Leukoreduced and Non-leukoreduced Whole Blood Transfusion in Uganda
Brief summary describing the background and objectives of the trial Blood transfusion is a life-saving intervention, but safety concerns exist especially in low- and middle-income countries (World Health Organization, 2017). Many safety concerns associated with blood transfusion have been linked to the presence of donor leucocytes in the blood product transfused. Benefits of leucoreduced blood transfusion have been demonstrated in high income countries where whole blood is primarily used in critically ill patients with substantial blood loss and where there is relatively adequate blood supply (Jones, Miller, Jansen et al., 2021); hence the results are not generalizable to sub-Saharan Africa. We recently demonstrated a high 30-day mortality rate (25.2%) in transfused patients in Uganda, where patients with cancer contributed a significant proportion (Okello, Shih, Angucia et al., 2022). In this current study, we hypothesized that patients with cancer could benefit from transfusion of leucoreduced whole blood. The objectives for this study were as follows: Primary objective 1. To compare the 30-day all-cause mortality rates in recipients of leucoreduced and recipients of non-leucoreduced whole blood transfusion at the Uganda Cancer Institute Secondary objectives 2. To determine the prevalence of RBC alloimmunization and specificity of RBC allo-antibodies in patients undergoing blood transfusion at the Uganda Cancer Institute. 3. To compare the incidence of RBC alloimmunization in recipients of leucoreduced and recipients of non-leucoreduced whole blood transfusion at the Uganda Cancer Institute.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2020
Actual trial start date 02/12/2020
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 278
Actual target sample size (number of participants) 277
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Leucoreduced blood transfusion As determined by the primary physician 30 days Transfusion with leucoreduced whole blood 137
Control Group Non leucoreduced blood As determined by the primary physician 30 days Transfusion with non-leucoreduced whole blood 140 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Patients admitted to adult ward in the Uganda Cancer Institute or Mulago hospital medical wards (aged 15 years and above) ii. Patients requiring blood transfusion iii. Patients who have provided a written informed consent/assent iv. Negative red blood cell allo-antibody test results at baseline 1. Participation in a competing study 2. Blood transfusion required within 30 minutes preventing the performance of pre-enrollment study procedures. 3. Blood or platelets products transfused in the previous 48 hours before study enrollment 4. Absence of compatible blood units at the time of enrollment 5. Previously enrolled in the same study 6. Failure to obtain pre-transfusion blood sample for testing. 7. Patients with altered mental status or comatose 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 99 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 03/09/2020 Makerere University College of Health Sciences School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O Box 7072 Kampala 0256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality 30 days
Secondary Outcome Prevalence and incidence of RBC alloimmunization 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Uganda Cancer Institute Upper Mulago Hill Road, Box 3935 Kampala 0256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Uganda Cancer Institute Upper Mulago Hill Road, Box 3935 Kampala 0256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Uganda Cancer Institute ADB project Upper Mulago Hill Road, Box 3935 Kampala 0256 Uganda Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clement Okello okdclement@gmail.com +256782352895 Upper Mulago Hill Road, Box 3935
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Investigator
Role Name Email Phone Street address
Public Enquiries Ezra Anecho ezraanecho@gmail.com +256750856488 Upper Mulago Hill Road, Box 3935
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Grants Officer
Role Name Email Phone Street address
Scientific Enquiries Nixon Niyonzima nniyonzima@gmail.com +256776677395 Upper Mulago Hill Road, Box 3935
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Director Research and Training
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial will be available after deidentification. Clinical Study Report,Statistical Analysis Plan Immediately after publication Data will be available to anyone who wishes to make use of them.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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