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临床试验/CTRI/2024/12/077801
CTRI/2024/12/077801尚未招募不适用

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

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
Incidence for intraoperative blood transfusion in pediatric oncological surgeries

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • a) Patients who will undergo chemo port insertion b) Patients who will undergo enucleation of eye.

结局指标

主要结局

Incidence for intraoperative blood transfusion in pediatric oncological surgeries

时间窗: At the end of the surgery

次要结局

  • 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)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bhakti Trivedi

Tata Memorial Centre

研究点 (1)

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