| 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
|
|
|
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
|
|
|
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. |