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CTRI Number  CTRI/2024/05/066995 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Observation of giving blood products to sick children 
Scientific Title of Study   Transfusion Practices in Critically Ill Children with Malignancy and their outcomes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4337_Version 1.0 dated 26 Sep 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpushp Bhosale 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpushp Bhosale 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital


MAHARASHTRA
400012
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpushp Bhosale 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital


MAHARASHTRA
400012
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept of Anaesthesia, Critical care and Pain, Second floor, Main building Tata Memorial Hospital 
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 Shilpushp Bhosale  Tata Memorial Hospital  Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
9619310657

shilbhosale@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: R70-R79||Abnormal findings on examination of blood, without diagnosis, (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 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:-
1. Age below 18yrs
2. Critically ill children admitted in ICU (for one year from the IEC approval and CTRI registration)
3. Patient who will receive at least one transfusion (PCV, FFP, Platelets, Cryoprecipitate, granulocytes etc) 
 
ExclusionCriteria 
Details  Exclusion Criteria:-
1. Refuses for consent or not able to obtain consent from participants LAR 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess all-cause mortality  Until ICU discharge or death 
 
Secondary Outcome  
Outcome  TimePoints 
Transfusion indication, triggers and efficacy   Until ICU discharge or death 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/05/2024 
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  

Introduction

Transfusion practices in critically ill children are standardised mainly with respect to packed red blood cell products.7 Use of platelet, plasma, cryoprecipitate and other products are still a focus of research. There is an increased risk of bleeding in critically ill children with cancer due to primary disease, organ dysfunction, including bone marrow suppression, hepatic insufficiency, consumptive or dilutional coagulopathy, concomitant medications like anticoagulants, invasive procedures, etc.1

They receive plasma and platelet transfusions to control and prevent bleeding. There is a considerable proportion of prophylactic transfusion in non-bleeding children. These transfusions are associated with increased length of stay, nosocomial infections and multiple organ failure, and mortality2. For children with leukemia, the number of transfusions received is an independent risk factor for poor survival.3

Children may have an increased rate of bleeding compared with adults. Many guidelines suggest thresholds for transfusion, but children with cancer are a unique cohort with challenges of concomitant coagulopathy and impaired platelet function. The thresholds change, rather become liberal in conditions of sepsis, hemodynamic instability, minor bleeding, fever; as clinicians tend to err on the side of caution.4.5 The decreasing or increasing trends also guide our decision. The risks of pre-surgical transfusions need to be weighed against the child’s underlying comorbidities, severity of illness, etiology of the coagulopathy, type of surgical procedure, risk of bleeding, and additional hemostatic measures.

Furthermore, blood products such as granulocyte, cryoprecipitate and modification techniques such as leucodepletion and gamma irradiation are also used in children in our centre. This is mainly owing to the unique population of oncological patients who suffer from bone marrow dysfunction and immunosuppressed states. Guidelines regarding the use of these blood products are sparse and lacking.8,9

The practice of using thresholds as indications or end points for transfusion is suboptimal as laboratory coagulation values and platelet counts are ex vivo measures applied to in vitro expectations of hemostatic balance. Hence, we propose this study to understand our transfusion practices and their outcomes better.

Our current practice is to transfuse packed red blood cell if the hemoglobin level is below 7 g/dL and platelet transfusion in non-bleeding children if the count is below 10,000/uml.6 Platelets are also transfused before invasive procedures to meet the pre-procedural criteria of 50,000. The plasma is transfused for invasive procedures when INR is above 1.5 in non-bleeding patients. Cryoprecipitate is provided to children with fibrinogen levels below 100 mg/dL. Granulocyte transfusion is reserved for critically ill children with profound neutropenia (absolute neutrophil count < 100 cells/mm3). The end points of therapeutic transfusion in bleeding patients varies from case to case basis.

The demographic data of patients will be recorded such as age, sex, weight, primary diagnosis, ICU diagnosis.

We aim to record

1.The percentage of patients receiving transfusion and number of occasions of transfusion.

2.Their indications- a) prophylactic when below the threshold or undergoing invasive procedure or b) therapeutic for active bleeding

3.Dose of transfusion i.e. volume ml/kg of PRBC/RDP/SDP/FFP/Cryo/Granulocyte including any modified product usage.

4.Pre and post transfusion investigations suggesting the threshold/trigger and efficacy

5.Associated organ dysfunction (suggested by organ support such as ventilation, vasopressors, renal replacement therapy)

6.Associated all cause mortality

7.Transfusion related reactions and adverse effects.

Sample Size:

Critically ill children admitted in the intensive care unit from the IEC approval and CTRI registration will be screened to enroll 200 participants

Statistical analysis:

Continuous variables will be presented as mean with standard vision or medians with interquartile range, and will be compared by Student’s t-test or Mann-Whitney U test. Univariate analysis using Chi-square test and unpaired t-test for categorical and continuous variables, respectively, will be done.

Step wise logistical regression analyses will be applied to assess the risk factors for the development of complications related to the transfusion and associated all cause mortality. Those considerable covariates (p < 0.10 or have important clinical significance) will be included in multivariate analysis. Interactions among the covariates in multivariate analyses will be tested by collinearity diagnosis. A P value < 0.05 (two-tailed) will be considered to be statistically significant.

 
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