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CTRI Number  CTRI/2024/12/077801 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to look at blood transfusions in cancer surgeries in children 
Scientific Title of Study   A prospective observational study to evaluate the blood transfusion practices in pediatrics surgeries at a tertiary care cancer institute in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4527_Version 1.1 dated 27.09.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhakti Trivedi 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9820333472  
Fax    
Email  bhaktiamit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhakti Trivedi 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9820333472  
Fax    
Email  bhaktiamit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohit Hooda 
Designation  Post Graduate student 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  7988456857  
Fax    
Email  mohit21hooda@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012, India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical care and Pain, Dr. E Borges Road, Parel, Mumbai, 400012  
Type of Sponsor  Research institution and hospital 
 
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 Bhakti Trivedi  Tata Memorial Centre  Department of Anesthesia Critical care and Pain, Second floor, Main Building
Mumbai
MAHARASHTRA 
9820333472

bhaktiamit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital_Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  We will be conducting a prospective analysis of pediatric patients in the age group of 1 month to 12 years who have undergone elective cancer surgeries at Tata Memorial Hospital during the period of 1st November 2024 to 31st October 2025 
 
ExclusionCriteria 
Details  a) Patients who will undergo chemo port insertion
b) Patients who will undergo enucleation of eye
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence for intraoperative blood transfusion in pediatric oncological surgeries  At the end of the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
a) To evaluate the indications of intraoperative blood transfusion in paediatric oncological surgeries.
b) To evaluate the transfusion trigger for intraoperative blood transfusion in paediatric oncological surgeries
 
At the end of the surgery 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   16/12/2024 
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  

Availability of safe and adequate blood supply is a public health challenge especially in low resource settings( country like India).(1) During surgeries, accounting for surgical blood loss and various clinical and laboratory values, transfusion of packed red blood cells (PRBCs) is often necessary to maintain hemodynamic stability and oxygen delivery.(2) Although blood is prescribed for many reasons based on firm belief that it improves oxygen carrying capacity, it carries many adverse hazards.(3) Also paediatric transfusions are different from adult transfusions with respect to indications, transfusion triggers, doses, frequency of adverse reactions. This becomes even more critical in paediatric patients with cancer. However, Transfusions are also known to be associated with multiple risks in children (including allergic reactions, transfusion-associated lung injury (TRALI), immunological risks, Hepatitis B and C and  HIV infection). The risk for occurrence of an adverse event such as a mistransfusion after allogenic blood transfusion is 1.3 times higher in children 1 year and older and 2.8 times higher in newborns (excluding premature infants) compared to adults.(4) Also, the rates of allergic reactions, febrile non haemolytic reactions, and acute haemolytic reactions are much higher in children than in adults. Thus, data on usage and patterns of blood transfusion is extremely important for rational usage of this scarce resource. 

Our study aims to evaluate the utilisation of intraoperative blood transfusion in paediatric patients undergoing oncological surgery at a tertiary care cancer institute in India.

 
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