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临床试验/NCT06425783
NCT06425783进行中(未招募)不适用

Warmed Blood Transfusion in Premature Babies Less Than 34 Weeks of Gestational Age: a Randomized Controlled Trial

Goztepe Prof Dr Suleyman Yalcın City Hospital2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
2
主要终点
Effect of heated blood transfusion on body temperature in premature babies

研究概览

简要总结

Premature babies have to deal with many problems from the moment they are born due to the immature of their organs. Their clinical condition is unstable, especially in the first few weeks, and they are greatly affected by environmental factors. During this period, blood transfusion may be needed for many reasons such as intraventricular hemorrhage and necrotizing enterocolitis. In addition, multiple blood draws to evaluate irregular metabolic, hematological and biochemical findings result in anemia and the need for blood transfusion. There are many algorithms regarding blood transfusion indications and transfusion limits in premature babies. However, there are no strict rules regarding the application of warming before blood transfusion, but it is recommended by some guidelines. Especially in unstable babies such as advanced premature babies, it is recommended to give blood by heating it at physiological temperature to avoid important complications such as hypothermia, coagulopathy and rhythm disturbances. Premature babies, whose hemodynamic and metabolic balance is very sensitive, may go into hypothermia when blood and products stored at +4C⁰ are given without heating. In routine practice, blood transfusion is performed without heating. The concern here is that hemolysis may develop by heating the blood. Studies have shown that hemolysis occurs when blood is heated above 46C⁰. In this study, physiological heating is planned. In vitro neonatal experimental modeling has shown that there is no hemolysis with physiological heating.

The aim of the researchers is; While protecting fragile, extremely premature babies from the complications of cold transfusion, the aim is to compare the transfusion groups with and without physiological heating in terms of hemolysis, metabolic balance and cerebral tissue oxygenation.

详细描述

This trial is planned to be randomized and controlled. Erythrocyte transfusion (ET) will be applied to premature babies born below the 34th gestational week, based on the limit values specified by TND, during Level 3 routine intensive care treatment and follow-up. They will be divided into two groups of 20 babies each: control and study groups. The control group will receive erythrocyte transfusion without heating, which is routinely applied. Heated ET will be performed on the study group by physiological warming between 34-36C⁰.

Procedures to be applied for the working group:

  1. ET requirement will be determined in line with the TND guide. It will be transfused at a standard dose of 20 ml/kg. Before ET is performed, blood gas and HTC, K and blood temperature before entering the heater will be measured and recorded.
  2. The erythrocyte suspension will be heated between 34-36 C⁰, which is the determined physiological temperature.
  3. Before giving it to the baby, 2 ml of blood will be taken through a triple tap and its hematocrit and K value (blood gas) will be checked. It will be given to the baby after the temperature is checked with a body fluid thermometer and determined to be within the appropriate range and if hemolysis is not observed.
  4. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K.

As standard for all babies during transfusion; Heart rate, blood pressure, saturation and body temperatures will be monitored.

It was planned to investigate whether there was a difference in terms of hypothermia and hemolysis between the groups with and without Physiological Heating. It will be examined whether heated blood has an effect on cerebral tissue perfusion by NIRS monitoring

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Double blind

入排标准

年龄范围
1 Hour 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Premature babies less than 34 weeks of gestation Babies requiring ES transfusions while receiving treatment in the NICU

排除标准

  • babies with severe congenital anomalies

结局指标

主要结局

Effect of heated blood transfusion on body temperature in premature babies

时间窗: 6 hours

The baby's body temperature will be measured and recorded before, during and after heated and unheated blood transfusions. It will be determined whether transfusion of unwarmed blood causes lower body temperature.

Effects of warming blood in blood transfusion on cerebral tissue oxygenation

时间窗: 8 hours

Cerebral tissue oxygenation will be measured with Near infrared spectroscopy (NIRS) monitoring in both transfusion applications. The data recorded on the NIRS device will be transferred to the computer and compared. The effect of warming the blood on cerebral tissue oxygenation will be demonstrated.

Effect of heated and unheated blood transfusion on hematocrit level

时间窗: 8 hours

After the heated and unheated blood transfusion ends, the hematocrit levels of the babies will be compared to determine which model is more effective.

次要结局

  • Effect of warming blood on potassium level(6 hours)
  • Effect of heated blood on blood lactate level(8 hours)
  • Effect of warming blood on LDH level(6 hours)

研究者

发起方
Goztepe Prof Dr Suleyman Yalcın City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Sevuk Ozumut

pediatric clinic chief assistant, MD

Goztepe Prof Dr Suleyman Yalcın City Hospital

研究点 (2)

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