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CTRI Number  CTRI/2025/11/097146 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to know how blood cell changes help in predicting the need for blood transfusion during major surgeries 
Scientific Title of Study   Red cell distribution width and heamoglobin ratio in relation to intraoperative blood transfusion in major surgeries 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Patlolla suraj reddy 
Designation  junior resident 
Affiliation  ESIC medical college  
Address  Department of Anesthesia,ESIC medical college sanathnagarhyderabad

Hyderabad
TELANGANA
500018
India 
Phone  7993405585  
Fax    
Email  surajreddy669@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAnanya Nanda  
Designation  Associate professor 
Affiliation  ESIC medical college 
Address  Room no-3021 Department of Anesthesia ESIC medical collegesanathnagarhyderabad

Hyderabad
TELANGANA
500018
India 
Phone  8179654082  
Fax    
Email  nanda.ananya@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAnanya Nanda  
Designation  Associate professor 
Affiliation  ESIC medical college 
Address  Room no-3021 Department of Anesthesia ESIC medical collegesanathnagarhyderabad

Hyderabad
TELANGANA
500018
India 
Phone  8179654082  
Fax    
Email  nanda.ananya@gmail.com  
 
Source of Monetary or Material Support  
ESIC MEDICAL COLLEGE AND HOSPITAL SANATH NAGAR ,DEPARTMENT OF ANESTHESIA  
 
Primary Sponsor  
Name  ESIC Medical College and Hospital 
Address  ESIC MMEDICAL COLLEGE AND HOSPITAL SANATHNAGAR HYDERABAD DEPT OF ANESTHESIA 
Type of Sponsor  Government 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 
ANANYA NANDA  ESIC MEDICAL COLLEGE AND HOSPITAL  ESIC SANATHNAGAR HYDERABAD DEPT OF ANESTHESIA OT COMPLEX 3 AND 4TH FLOOR
Hyderabad
TELANGANA 		 8179654082

nanda.ananya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Elective major surgeries
pre op RDW and Hb measurements available  
 
ExclusionCriteria 
Details  Emergency surgeries
Pre existing hematologic disorders
chronic transfusion recipients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO PREDICT INTRAOPERATIVE BLOOD TRANSFUSION REQUIREMENT BASED ON PRE-OPERATIVE HEMOGLOBIN AND RED CELL DISTRIBUTION WIDTH RATIO   PRE-OPERATIVE HEMOGLOBIN AND RED CELL DISTRIBUTION WIDTH RATIO 
 
Secondary Outcome  
Outcome  TimePoints 
EXPLORING THE RELATIONSHIP BETWEEN HEMOGLOBIN AND RED CELL WIDTH DISTRIBUTION FOR BLOOD MANAGEMENT STRATEGIES  INTRAOPERATIVELY  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/11/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 17-01-2027 and end date provided 17-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   ALL THE PATIENTS UNDERGOING MAJOR SURGERY WILL BE SELECED AND BLOOD INVESTIGATIONS WILL BE COLLECTED WHICH HAS BEEN DONE PREVIOUSLY. THE LAB VALUES INCLUDING RDW and hemoglobin levels will be obtained . rdw value will be obtained in percentage abd HB leve will be recorded. the ratio will be calculated . The intraoperative blood loss will also noted down.  
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