| CTRI Number |
CTRI/2024/06/068524 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Blood utilisation in replacement surgery |
|
Scientific Title of Study
|
Study to assess maximum surgical blood ordering schedule in hip or knee
arthroplasty at a tertiary center. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragath Janardhan T |
| Designation |
Postgraduate ,Department of Anaesthesia |
| Affiliation |
Yenepoya Medical College |
| Address |
Yenepoya Medical College hospital and research centre,
Yenepoya(deamed to be )college
Yenepoya University Campus, Deralakatte,
Mangalore 575018
Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
09480706263 |
| Fax |
|
| Email |
pragathjanardhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Smita Musti |
| Designation |
Associate professor ,Department of Aneathsesia |
| Affiliation |
Yenepoya Medical college |
| Address |
Dept of anaesthesiology , Yenepoya Medical College hospital and research centre, Yenepoya(deamed to be )college
Yenepoya University Campus, Deralakatte,
Mangalore 575018
Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Smita Musti |
| Designation |
Associate professor ,Department of Aneathsesia |
| Affiliation |
Yenepoya Medical college |
| Address |
Dept of anaesthesiology , Yenepoya Medical College hospital and research centre, Yenepoya(deamed to be )college
Yenepoya University Campus, Deralakatte,
Mangalore 575018
Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya medical college and research hospital
Yenepoya deemed to be University
University Road, Deralakatte, Ullal,Mangalore,Karnataka, India, 575018. |
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College |
| Address |
Yenepoya Medical College ,
Yenepoya(Demmed to be )
Yenepoya University Campus, Deralakatte,
Mangalore 575018
Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 Pragath Janardhan T |
Post op recovery ward, 6th floor, Yenepoya Medical college hospital |
Yenepoya Medical College ,
Yenepoya(Demmed to be )
Yenepoya University Campus, Deralakatte,
Mangalore 575018
Karnataka Dakshina Kannada KARNATAKA |
9480706263
pragathjanardhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patient aged between 18-65 years posted for hip or knee arthroplasty in whom, packed RBC request will be raised for the purpose of intra operative and post operative transfusion and resuscitation. |
|
| ExclusionCriteria |
| Details |
1. Patient who underwent recent cardiac surgeries, gynecological and obstetric procedures, polytrauma in less than 3 months prior to the study
2. Patient who needed pre-operative blood transfusion for optimization for surgery (with hemoglobin less than 10 or hematocrit less than 30)
3. Patients who had ongoing blood losses in spite of adequate hematologic parameter (with hemoglobin more than 10 or hematocrit more than 30)
4.Deranged coagulation profile |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre-operative haemoglobin level |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To estimate the number of patients who underwent cross matching & number of PRBC units arranged for each patient.
2.To assess if there is any relation between the intraoperative blood loss, PRBC transfusion & PRBC reserved. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "232"
Final Enrollment numbers achieved (India)="232" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/09/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Overordering of blood has been a challenge faced by the blood bank staff1. The present study addresses the role of maximum surgical blood ordering schedule (MSBOS) in optimizing the blood inventory management. The reason behind the study is to determine the efficiency of blood ordering methods for hip or knee arthroplasty surgeries in Yenepoya medical college hospital. The increasing demand for blood and blood products together with rising cost is a major healthcare problem. Previous studies have indicated gross over ordering of blood much in excess of actual needs. There are two main reasons for over ordering of blood. First, is the growing real demand for blood. The second is that most of the surgeons and anesthesiologist over-order blood for specific recipients, because they are not sure about easy access to blood when it is needed. Therefore, it is held in reserved status for that person and will not be used for other patients. In practice, such blood may become outdated during reserved period, therefore it is essential to formulate a blood ordering system so that excessive or even unnecessary blood ordering is prevented. This study aims to assess the blood utilization in hip or knee arthroplasty surgeries and to formulate MSBOS. The term MSBOS has been used to describe a list of common elective surgeries with the maximum number of units of blood to be cross matched pre-operatively. This will not only prevent the wastage of blood but also decreases the cost and blood bank over loads. |