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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310892230317 Date of Registration: 05/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Jini Na Project
Official scientific title Safe Blood for Kano: Cross-sectional and longitudinal population-based study on blood donor and transfusion recipient characteristics in Northern Nigeria
Brief summary describing the background and objectives of the trial It is unequivocally accepted that there are not enough blood donors in sub-Saharan Africa. Data on blood donors and recipients is minimal and mostly retrospective. The healthcare system in Nigeria has achieved a level, at which blood transfusion has become an important support to manage patients with various diseases. These patients can be treated appropriately by the local infrastructure, but require blood transfusion during the critical phase. Planning strategies to secure a safe blood supply requires data. These data are not available for most regions in sub-Saharan Africa including Nigeria. The established infrastructure in Kano state, Nigeria, and the already active collaboration network between the blood banks in Kano provides the unique chance to generate data regarding blood needs and blood supply for a population of >2 million. Besides information on blood donors and blood products, we will generate data on transfusion recipients: e.g. elective surgery, obstetrics, pediatrics, trauma, sickle cell anemia. These are the vulnerable groups explicitly named in the national health policy goals. The data generated in our study are likely representative of Nigeria, a country with a population of about 250 million. And potentially also for many regions in sub-Saharan Africa. This observational, longitudinal Phase 4, multi-center study is set to identify the characteristics of blood donors and transfusion recipients in 10 hospitals in Kano, Kano State Nigeria. The study will also assess the fate of the donated blood products and potential transfusion reactions. The study will answer the following questions: - How many blood units are donated annually in Kano metropolis? - Who are the blood donors? type, gender, age, and motivation? - How many patients are transfused? - Who are the transfused patients? - Which blood products are used? - How many blood units are wasted?
Type of trial Observational
Acronym (If the trial has an acronym then please provide) Jini Na Project
Disease(s) or condition(s) being studied Blood Transfusion
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Blood Transfusion
Anticipated trial start date 25/09/2023
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Single Group Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Blood transfusion and blood donors We will describe the characteristics of blood donors and blood transfusion recipients to answer the following questions; 1. How many blood units are donated during one year in the Kano metropolitan area? - Who are the blood donors? voluntary-, family-replacement-, paid donors; sex, age, motivation? - How many patients are transfused? - Who are the transfused patients, medical, surgical, trauma, postpartum hemorrhage, pediatric? - Which blood products are used?: whole blood, components? - How many blood bags are wasted? - How often is blood not donated because of an insufficient supply of consumables? 1 year All blood donors who present to the different collaborating hospitals will be recorded; their demographic characteristics, motivation for donation, and screening results for transfusion-transmitted infections (HIV, HBV, HCV, and Syphilis). All transfusion recipients at the different collaborating hospitals will be recorded; their demographic characteristics, indications for transfusion, outcome of transfusion 50000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All blood donors and transfusion recipients in 10 hospitals in the region of the city of Kano, Nigeria; Fulfilling Nigerian criteria for blood donation (for blood donors); Hemoglobin of >12.5g/dl and 13.5g/dl (females and males respectively), Negative rapid screening test for Transfusion Transmitted Infections (TTIs). All subjects in whom the treating physician defined an indication for blood transfusion will be enrolled. All subjects with exclusion criteria for blood donation according to the Nigerian regulations. 1. Hemoglobin < 12.5g/dl and 13.5g/dl in females and males respectively 2. Evidence for the presence of TTI, HIV, HBV, HCV, VLDR, 3. Severe infection 4. Fever 5. Body weight < 50 kg 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 65 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 31/05/2023 Aminu Kano Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zaria road Kano 700233 Nigeria
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 27/04/2023 Kano State Health and Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Post Office Road Kano 700213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome How many blood units are donated during one year in the Kano metropolitan area? - Who are the blood donors?: voluntary-, family-replacement-, paid donors; sex, age, motivation? - How many patients are transfused? - Who are the transfused patients, medical, surgical, trauma, postpartum hemorrhage, pediatric? - Which blood products are used: whole blood, components? - How many blood bags are wasted? End point
Secondary Outcome How often can blood not be donated because of insufcient supply? End point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria Road Kano 700233 Nigeria
Murtala Muhammed Specialist Hospital Kano Rimi Market Street Kano 700251 Nigeria
Muhammed Abdullahi Wase Teaching Hospital Kano Abdullahi Bayero Road Kano 700222 Nigeria
National Orthopedic Hospital Dala Kano Kofar Ruwa Road Kano 700252 Nigeria
Waziri Gidado General Hospital Kano Rijiyar Lemo Kano 700252 Nigeria
Sir Muhammadu Sanusi General Hospital Kano Yankaba Hadeja Road Kano 700214 Nigeria
Sheikh Muhammed Jidda General Hospital Fagge Road Kano 700213 Nigeria
Sabo Bakinzuwo Maternity Hospital Jakara Road Kano 700252 Nigeria
Khalifa Isyaku Rabiu Paediatric Hospital Zoo Road Kano 700224 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
German Research Foundation 65760 Eschborn Germany 65760 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute of Transfusion Medicine University of Greifswald Sauerbruchstrasse Greifswald 17475 Germany Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. med. Andreas Greinacher Sauerbruchstrasse Greifswald 17475 Germany
Dr. Kathleen Selleng Sauerbruchstrasse Greifswald 17475 Germany
Prof. Dr. Aisha Kuliya Zaria Road Kano 700233 Nigeria
Dr Dalhat Gwarzo Zaria Road Kano 700233 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aisha Kuliya akgwarzo.hae@buk.edu.ng +2348036030099 Zaria Road
City Postal code Country Position/Affiliation
Kano 700233 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries Andreas Greinacher andreas.greinacher@med.uni-greifswald.de +493834865482 Sauerbruchstr 1
City Postal code Country Position/Affiliation
Greifswald 117475 Germany Professor
Role Name Email Phone Street address
Scientific Enquiries Kathleen Selleng kathleen.selleng@med.uni-greifswald.de +493834865482 Sauerbruchstr 1
City Postal code Country Position/Affiliation
Greifswald 17475 Germany Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Investigator(s) will respect and protect the confidentiality of the subjects in all possible ways. Subject identification, other than subject number, will not appear in any eCRF pages or any other documents given to the Sponsor. Only the Investigator and the persons authorized to verify the quality and integrity of the study will have access to subject records where the subject can be identified. The source documentation for data generated by this study must be available for inspection by designees of health authorities, the Sponsor or their designees, and the IEC/IRB. These are the registers in the donor clinic, and the patient files. Statistical Analysis Plan,Study Protocol Not yet assigned Not yet assigned
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