| CTRI Number |
CTRI/2024/10/075861 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Centralised Blood Inventory Management System Evaluation |
|
Scientific Title of Study
|
Evaluation of the Centralised Blood Inventory Management System in Enhancing Blood Inventory Management, Quality Assurance, and Donor Tracking Across Blood Banks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AVS Suresh |
| Designation |
Visiting Consultant |
| Affiliation |
CR Healthcare |
| Address |
Oncology Department, Modern Medicine division, Visiting consultant, KIMS, Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
9246243034 |
| Fax |
|
| Email |
attilivss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sri Harsha Setti |
| Designation |
Research Project Manager |
| Affiliation |
CR Healthcare |
| Address |
Clinical Research Department, Modern Medicine division, KIMS, Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
8977511526 |
| Fax |
|
| Email |
drharsha@medunited.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Keerthana Kalidindi |
| Designation |
Project Manager |
| Affiliation |
CR Healthcare |
| Address |
Clinical Research Department, Modern Medicine division, KIMS, Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
9346052827 |
| Fax |
|
| Email |
keerthana.k@medunited.in |
|
|
Source of Monetary or Material Support
|
| Konaseema Institute of Medical Sciences & Research Foundation - [Self] Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201 |
|
|
Primary Sponsor
|
| Name |
konaseema institute of medical sciences Although funded by self |
| Address |
Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201 |
| Type of Sponsor |
Other [Self - Investigator initiated trial ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AVS Suresh |
Konaseema Institute of Medical Science & Research Foundation |
Oncology Department, Modern Medicine division, Visiting consultant, KIMS, Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201
East Godavari
ANDHRA PRADESH |
9246243034
dr.suresh@techsophy.com |
| Dr Sri Harsha Setti |
Konaseema Institute of Medical Science & Research Foundation |
Clinical Research Department, Modern Medicine division, Research project manager KIMS, Chaitanya Health City, NH216, Amalapuram, Andhra Pradesh 533201
East Godavari
ANDHRA PRADESH |
8977511526
drharsha@medunited.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Konaseema Institute of Medical Science & Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers eligible and willing to donate blood |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Blood banks must be willing to participate and consent to the study.
The blood banks must be located in geographically diverse regions.
The blood banks must agree to use the BIMS system for the full duration of the study.
Each blood bank must scan 200 blood bags using BIMS. |
|
| ExclusionCriteria |
| Details |
Blood banks that do not have the technical capability to implement BIMS.
Blood banks that are not willing to participate for the entire study period.
Blood banks with fewer than 200 blood bags to be scanned during the study period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of errors in blood grouping, viral screening, and avoidance of repeat donors by linking with phone or other identifiers. |
Month 1: Recruitment of blood banks, training sessions, and baseline data collection.
Months 2-7: Implementation of BIMS, ongoing data collection, and monitoring.
Month 8: Data analysis and review.
Month 9: Report writing and dissemination of results.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Minimization of Blood Wastage
Increased Transparency
Improved Donor Communication
System Integration
Quality Assurance Improvement |
Month 1: Recruitment of blood banks, training sessions, and baseline data collection.
Months 2-7: Implementation of BIMS, ongoing data collection, and monitoring.
Month 8: Data analysis and review.
Month 9: Report writing and dissemination of results.
|
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
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)
|
11/11/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Purpose
The primary purpose of the protocol is to evaluate the effectiveness of the Centralized Blood Inventory Management System (BIMS) in enhancing blood inventory management, quality assurance, and donor tracking across blood banks. The study aims to determine whether the implementation of BIMS can reduce errors in blood grouping and viral screening, minimize blood wastage, increase transparency in operations, and improve communication with potential donors, particularly during emergencies.
Hypothesis
The hypothesis is that the BIMS will significantly reduce errors in blood processing and management while also improving the efficiency and transparency of blood bank operations, compared to existing systems. The study expects BIMS to enhance the ability of blood banks to track donors and manage inventory more effectively. |