A retrospective observational study to evaluate the blood transfusion practices inpaediatric surgeries at a tertiary care cancer institute in India

INTRODUCTION

Availability of safe and adequate blood supply is a public health challenge especially in low resource country like India. 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. 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, PRBC transfusions are also known to be associated with multiple risks in children like allergic reactions, transfusion-associated lung injury (TRALI), immunological risks, risk of transmitting Hepatitis B and C, HIV and other infections The risk 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. Also, the rates of allergic reactions, febrile non hemolytic reactions, and acute hemolytic 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 utilization of intraoperative blood transfusion in paediatric patients undergoing oncological surgery at a tertiary care cancer institute in India.

AIMS AND OBJECTIVES

 Ã˜ PRIMARY OBJECTIVE

To evaluate the incidence for intraoperative blood transfusion in paediatric oncological surgeries at a tertiary care cancer institute in India.

MATERIALS AND METHODS

STUDY DESIGN

This is a retrospective, observational study. The study will be conducted in the department of Anaesthesiology, Critical Care and Pain at Tata Memorial Hospital, Mumbai

 Ã˜ INCLUSION CRITERIA

We will be conducting a retrospective analysis of paediatric 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 June 2019 to 31st May 2022.

Ø EXCLUSION CRITERIA

a)    Patients with missing data

b)    Patients who have undergone chemoport insertion

c)    Patients who have undergone enucleation of eye

Ø STUDY METHODOLOGY

Data will be collected from the electronic medical record (EMR) system of the hospital which has the patient’s clinical and laboratory data.

Following details will be collected

a)    demographic data

b)    preexisting comorbidities and the treatment

c)     American Society of Anesthesiologists (ASA) classification

d)    primary diagnosis

e)    clinical details including details of preoperative chemotherapy, radiotherapy

f)     indication for surgery

g)    Preoperative Hb , coagulation profile

h)    Blood crossmatch with self or mother

i)     duration of surgery

j)     Any vascular injury during surgery

k)    amount of intraoperative crystalloid and colloid fluid

l)     Total intraoperative urine output

m)  estimated intraoperative blood loss

n)    intraoperative blood transfusion: The number and volume of PRBC and other blood products(albumin, fresh frozen plasma, platelets, cryoprecipitate) transfused were recorded

o)    Total duration of intraoperative hypotension

p)    Any need of vasopressors intraoperative

q)    Hb on postoperative day 1

r)     length of ICU stay

s)    length of hospital stay

t)     complications during hospital stay including mortality

u)     Hb concentration at discharge.

The data collected will be stratified into three groups depending on the age of the patient as follows

a)    Group 1: patients in the age group of 1month to 3 years

b)    Group2: : patients in the age group of 3 years to 6 years

c)    Group3: : patients in the age group of 6 years to 12 years

 Ã˜  LOCATION OF THE STUDY

The study will be conducted in Tata Memorial Hospital,Mumbai

 Ã˜  DURATION OF THE STUDY

The study is a retrospective observational study and data collected will be from 1st June 2019 to 31st May 2022.The study will be completed in one year.

 Ã˜  PRIVACY AND CONFIDENTIALITY-

The information that will be collected from this study will be kept confidential and anonymous and will be stored securely in the personal computer of the PI and will not be disclosed.

    Ø  ETHICAL CONSIDERATIONS AND SAFEGUARDS

As this is a retrospective observational study, there will be no direct contact with the patient and all data will be collected from the EMR and from anesthesia notes. There will be no violation of the rights of the participants involved in the study.

 Ã˜  STASTICAL ANALYSIS PLAN

Descriptive analysis will be used to summarize patient characteristics at baseline.

·      Continuous variables will be presented as the mean ± standard deviation (SD) or Median (IQR) based on normality of the data.

·      Categorical data will be presented as numbers (percentages).

·      Normality of data will be assessed using Shapiro Wilk test.

·      The incidence for intraoperative blood transfusion in pediatric patients will be reported as counts (percentage) with 95% confidence interval.

·      Descriptive and univariate logistic analyses will be initially conducted to compare the demographic characteristics, comorbidities, preoperative laboratory values, and operative variables between the transfusion group and non-transfusion group.

·      A multivariable logistic regression model will be used to examine independent risk factors for blood transfusion. A stepwise backward LR selection method will be used for the multivariable logistic regression model.

·      P value < 0.05 will be considered statistically significant.

·      All analysis will be two sided, and significance will set at a p-value of 0.05.

·       Statistical analyses will be performed using SPSS (the statistical package for social sciences) IBM Corp. Released 2017.IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.