| CTRI Number |
CTRI/2024/02/062186 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood use pattern assessment in medical college |
|
Scientific Title of Study
|
Assessment of Blood usage pattern by analyzing blood utilization indices at Blood Centre: A cross sectional study |
| 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 Saumya Mishra |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Ac boys hostel, Room no. 2, Rohilkhand medical college and hospital, Pilibhit Bypass road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8874887438 |
| Fax |
|
| Email |
saumy96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anjana Arya |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of pathology, Room no. 1164, Rohilkhand medical college and hospital, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9412125824 |
| Fax |
|
| Email |
anjanaarya.singh15@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saumya Mishra |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Ac boys hostel, room no. 2,Rohilkhand medical college and hospital, Pilibhit Bypass road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8874887438 |
| Fax |
|
| Email |
saumy96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Blood centre, Rohilkhand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Saumya mishra |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya Mishra |
Department of pathology, Rohilkhand medical college and hospital |
Blood centre, Department of Pathology,Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly Bareilly UTTAR PRADESH |
8874887438
saumy96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, RMCH,Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All transfusion requests made by clinicians from different wards of the hospital, irrespective of age and gender. |
|
| ExclusionCriteria |
| Details |
Performa with incomplete and improperly filled details on blood transfusion will be excluded.
Blood bags issued for the patients who are not admitted in RMCH. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the pattern of utilization of blood components according to age, sex, and clinical indications. To determine the blood utilization indices. To correlate blood utilization indices with usage pattern. |
Monthly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood component usage pattern in medical college |
Monthly |
|
|
Target Sample Size
|
Total Sample Size="5000" Sample Size from India="5000"
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)
|
06/02/2024 |
| 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="0" 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
|
The study will be conducted in Blood Centre, RMCH, Bareilly and will include all requisitions for blood component made by clinicians from different wards during the study duration after taking approval from the Institutional Ethics Committee and consent from blood donor. Data will be collected data from the donar register, stock register, cross match register, master register, issue register and from the requisition form that will be made by clinician. Data will be collected data from the master register like unit no, unit blood group, type of blood bag use, date of expiry of each component. Data will be collect data from issue register. Details of component, department/ ward name and diagnosis of patient for which we issue the component are documented in this register. Data will also be collected from requisition forms which will include the details of patient like age, gender, blood group, department/ward name, diagnosis and number of component demand for patient. We will study utilization of blood and components in various departments including surgery, obgy and gynae, orthopaedics, ENT, radiation and oncology and other non surgical department like medicine, paediatrics and chest and TB. Blood analyse indices will be computed with following equation using MS excel: A) C/T ratio10 = total number of units cross-matched / total number of units transfused. Ideally this ratio should be 1.0 Value 2.5 and below indicates significant blood usage. B) Transfusion index (TI)10 = Number of units transfused / Number of patient cross-matched Value 0.5 or more is indicative of significant blood utilization. C) Transfusion probability (T%)10 = Number of patient transfused / Number of patient cross-matched X 100 Value 30% and above indicates significant blood usage. |