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CTRI Number  CTRI/2024/09/074024 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective longitudinal study 
Study Design  Other 
Public Title of Study   Studying Repeat Blood Donors to Improve Blood Supply 
Scientific Title of Study   A Comprehensive assessment of Repeat Blood Donation Pattern for Strengthening/Optimizing Donor pool 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Singh 
Designation  Junior Resident 
Affiliation  Blood Bank of Kasturba Medical College 
Address  Department of Community Medicine, KMC, MAHE , Manipal Udupi
Blood Bank, Department of Hematology, Kasturba medical college, MAHE, MANIPAL
Udupi
KARNATAKA
576104
India 
Phone  9779979529  
Fax    
Email  sandeepsingh79529@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kirthinath Ballala 
Designation  Associate Professor 
Affiliation  MAHE, Manipal 
Address  Department of Community Medicine, KMC, MAHE , Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9844270050  
Fax    
Email  kirthinath.ballala@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Kirthinath Ballala 
Designation  Associate Professor 
Affiliation  MAHE, Manipal 
Address  Department of Community Medicine, KMC, MAHE , Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9844270050  
Fax    
Email  kirthinath.ballala@manipal.edu  
 
Source of Monetary or Material Support  
Post graduate grant Kasturba Medical College, MAHE, Manipal, Karnataka, India -576104 
 
Primary Sponsor  
Name  KMC, MAHE, Manipal 
Address  Department of Community Medicine, KMC , MAHE , Manipal 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Singh  Kasturba medical college, MAHE, MANIPAL  Blood Bank, Department of Hematology, Kasturba medical college, MAHE, MANIPAL
Udupi
KARNATAKA 
9779979529

sandeepsingh79529@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Blood donors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  DGHS Guidelines will be followed 
 
ExclusionCriteria 
Details  Patients with HIV, HbsAg, Anemia etc (conditions which are contra-indicated for blood donation) will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Study the profile of blood donors in a tertiary care centre in south India  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Development and validation of AI prediction model to predict repeat blood donation among donors visiting Kasturba Hospital Manipal  18 months 
Measure the effect of incorporation of motivators and barriers in the AI predictive model   18 months 
 
Target Sample Size   Total Sample Size="438"
Sample Size from India="438" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1.        To study the profile of blood donors in a tertiary care centre in south India

 

Study design: Retrospective study

Study settings: Department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal

Study period: Date of obtaining ethical clearance to next 3 months.

Inclusion criteria: Data of all the adults age > 18 years who have donated blood at the department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal in the last 3 years will be considered for the study. DGHS guidelines will be followed [7].

Sample size:There are approximately 15,000 blood donations every year at Kasturba Hospital, Manipal. Hence over a period of 3 years data of approximately 45,000 blood donors will be collected.

Sampling technique: Complete enumeration of the profile of all the blood donors will be done.

Methodology: Data will be collected using a pre-designed pre-tested data abstraction form. The data abstraction form will contain-1. socio-demographic information of study participants like name, age, gender. 2. Anthropometric details- height, weight 3. Blood pressure 4. Temperature 5. Lab investigations- blood group, CBC.

Outcome measures: Profile of repeat blood donors and one-time donors will be assessed.

Statistical analysis: Data will be entered in Microsoft excel and analysed using Jamovi software. Categorical data will be expressed as percentages and proportions. Continuous variables will be summarised as mean and standard deviations. Chi square test will be conducted to study the determinants significantly associated with repeat blood donors and one-time donors.

 

2.       Scoping review

A scoping review will be conducted based on a scoping review framework (Arksey & O’Malley, 2005) and the Methodology for Joanna Briggs Institute (JBI) Scoping Reviews (The Joanna Briggs Institute, 2015). Identified studies will be selected for the review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) of health care interventions. Data extraction and a thematic analysis will be conducted. The research question used will be- What are the motivators and barriers for voluntary blood donation among donors in Low- and middle-income countries. Relevant literature will be identified in the following database- PubMed, EMBASE, Scopus, Web of Science. All the relevant articles in the last 10 years, starting from January 2014 till date will be considered. Appropriate search criteria will be developed using MeSH terms.

The selected literature will be evaluated for its significance and relevance based on the content and the publication type.

Inclusion criteria: It can include original articles, review articles, systematic reviews, case report and series. Only articles published in English will be included.

Exclusion criteria: Editorials, unpublished manuscripts, conference abstracts.

The eligibility criteria will be used to perform a preliminary screening of the articles based on their titles and abstracts. After identifying the articles in the aforementioned databases, they will be imported to Rayyan Software, where duplicated will be removed. Two reviewers will select the titles and abstracts of potentially eligible studies,  which will then be reviewed at full text by two reviewers. These procedures  will be carried out independently and disagreements will be resolved by discussion until a consensus is reached. If consensus is not reached between the two reviewers, the opinion of a third reviewer will be considered.

Charting the data

A data extraction form will be used to study characteristics like Authors, Year of Publication, Country of origin of study, study design, Population, intervention, context, outcome.

3.       Development and validation of AI prediction model to predict repeat blood donation among donors visiting Kasturba Hospital Manipal& To measure the effect of incorporation of motivators and barriers in the AI predictive model

 

Development of AI prediction model-1

An AI predictive model to predict repeat blood donation by the donors will be built with the help of the Department of Computer Science, Manipal Institute of Technology, Manipal. The data obtained from the department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal of voluntary blood donors who have donated blood in Kasturba Hospital in the last 3 years will be used to build the AI predictive model-1. The predictive model will be built based on the following information that is recorded from the donors- 1. Socio-demographic information of study participants like age, occupation, education etc,2. Anthropometric measurements namely height and weight, 3. Blood pressure 4. Lab investigations- CBC, blood group 5. Temperature.

Development of AI prediction model-2

The investigator will telephonically contact the list of repeated blood donors as well as one-time blood donors from the data set available in the department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal. All the adults age > 18 years whose data is available, satisfying the inclusion criteria of the 1st objective will be considered eligible for the study.

Sample size: According to a previous study conducted by Narayanan D et al [8] in Khozikode, Kerala the most important motivational factor for blood donation was desire to help others which was seen in 58.5 % blood donors. Considering this prevalence and using the formula for prevalence to calculate sample size, for a precision of 10%

Sample size= 4PQ/D2, where P=Prevalence, Q=1-P, D= level of precision

The desired sample size is 97. Considering 10% non-response the sample size is 107. Hence, we will be recruiting 107 one-time donors and 107 repeat blood donors.

Sampling technique: Random sampling will be employed to select the required number of samples using random number table.

Methods: Questions regarding motivators and barriers for blood donation will be asked to the participants after obtaining their informed consent. The scoping review conducted will be used as aid to formulate questions regarding motivators and barriers for voluntary blood donation among donors. These questions will be asked to 107 repeated blood donors and 107 participants who are not repeated blood donors from the list of last 3 years voluntary blood donors available at the department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal through telephonic interview using a pre-designed semi-structured questionnaire which comprises questions on motivators and barriers for blood donation. Help of the counsellor in the department of Haematology and blood transfusion will be obtained for the telephonic interview of participants. The most common motivators and barriers will be listed. These parameters regarding the most common motivators and barriers will be fed into the already developed AI predictive model (AI Predictive model-1) to obtain a modified AI predictive model (AI Predictive model-2).

 

 

Validation of the AI predictive models

Study design: Prospective longitudinal study

Study settings: The study will be conducted at the department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal

Study period: Date of obtaining Ethical clearance to July 2026

Inclusion criteria:All the adults age > 18 years attending the department of Immuno-Haematology and Blood Transfusion, Kasturba Hospital, Manipal will be considered eligible for the study. DGHS guidelines will be followed [7].

Exclusion Criteria: Patients with HIV, HbsAg, Anemia etc (conditions which are contra-indicated for blood donation) will be excluded.

Sample size: According to a previous study conducted by Uma S et al [7] in Chennai the prevalence of repeated blood donation among blood donors was 53.7%. Considering this prevalence and using the formula for prevalence to calculate sample size, for a precision of 5%.

Sample size= 4PQ/D2, where P=Prevalence, Q=1-P, D= level of precision

The desired sample size is 398. Considering 10% non-response rate the sample size is 438.

Sampling technique: Convenient sampling will be employed to select 400 blood donors visiting the department of haematology and blood transfusion, Kasturba Hospital, Manipal for blood donation.

Methods:

All the participants meeting the inclusion criteria will be administered a pre-designed questionnaire after obtaining their informed consent (interview personally) .The data collection tool will consist of 1. Socio-demographic information of study participants like age, occupation, education etc, 2. Anthropometric measurements namely height and weight, 3. Blood pressure 4. Lab investigations- CBC, blood group 5. Temperature.

Weight: will be measured to the nearest 100 gms, in light clothing, using a standard weighing machine after correcting the zero error.

Height: will be measured to the nearest 0.5 cm with the person standing upright against the wall with heels together and touching the wall, and the head held in upright position.

Blood pressure: Blood pressure will be recorded using a calibrated mercury sphygmomanometer. Blood pressure will be taken in sitting position and in the right arm. Appearance of first sound of Korotkoff (phase 1) will be taken as systolic and total disappearance (phase 5) of Korotkoff sound will be taken as diastolic BP. Blood pressure will be taken once the person was relaxed. Two readings will be taken atleast 10 mins apart and average of 2 readings will be taken.

All the above data will be fed into the AI prediction model-1 and the prediction as to whether the person is a potential repeated blood donor or not will be given by the model. The patients will be contacted after 1 year telephonically and will be asked whether they have donated blood again or not. Following analysis will be conducted using the AI prediction model-1 i.e; Sensitivity, specificity, positive predictive value and negative predictive value.

Simultaneously the data regarding motivators and barriers will be fed into the AI predictive model-2 and the prediction as to whether the person is a potential repeated blood donor or not given by the model will be noted. Information obtained from the aforementioned telephonic follow up of the participants will be used to calculate Sensitivity, specificity, positive predictive value and negative predictive value of the AI predictive model-2.

 
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