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临床试验/CTRI/2026/01/101336
CTRI/2026/01/101336尚未招募不适用

Liberal VS Restrictive TRansfusion thresholds In Pediatric Patients with Septic Shock: A randomised controlled trial

AIIMS1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
140
试验地点
1

研究概览

简要总结

The optimal threshold for PRBC transfusion remains a clinically relevant question in contemporary pediatric critical care. Very few studies have investigated the optimal transfusion thresholds in patients with sepsis, and even fewer in patients with septic shock. Current recommendations by the Surviving Sepsis Campaign, published in 2020, recommend against transfusing hemodynamically stabilized children with septic shock with a hemoglobin of more than  equal to 7 g/dL; however, specific recommendations for unstable septic shock patients remain limited due to a lack of evidence.6  The Pediatric Critical Care Transfusion and Anemia Expertise Initiative TAXI has provided nuanced recommendations for hemodynamically unstable and stable children. For hemodynamically stable children, they recommend against transfusing at a hemoglobin of more than 7 g/dl, while acknowledging that for unstable children, a higher hemoglobin may be beneficial, and that a lack of evidence precludes them from recommending thresholds in such children.

There is thus a pressing need for further studies that help determine optimal transfusion thresholds in critically ill children with septic shock and hemodynamic instability, preventing undue exposure to blood products and infections while also optimising oxygen delivery in a background of compromised perfusion. We, thus plan to conduct this study to determine whether a restrictive or a liberal transfusion threshold is optimal for transfusion in patients with septic shock.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
28.00 Day(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Children admitted to PICU Aged 28 days to 17 years Meeting Phoenix criteria for septic shock Hemoglobin less than 9 g per dl.

排除标准

  • Patients with malignancies Patients with hemolytic anemias Patients with a hemoglobin level less than 5 g per dl Patients with cyanotic Congenital Heart Disease Patients with Chronic Kidney Disease Patients with an anticipated mortality in the next 24 hours post randomisation Patients who were administered PRBCs during this admission before the child developed shock Life-threatening bleed Need for a surgical procedure requiring higher hemoglobin levels Dengue Shock.

研究者

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

Samprati Agrawal

All India Institute of Medical Sciences

研究点 (1)

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