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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  
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 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  
Status 
Not Applicable 
 
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.

                                                                                                                                                                                                                                                                                                   

 
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