Warmed Blood Transfusion in Premature Infants

Goztepe Prof Dr Suleyman Yalcın City Hospital

Status: Active, not recruiting

Conditions: Premature; Transfusion Related Complication

Treatments: Procedure: Warmed Blood Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06425783

SYNEO-03

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 1 hour to 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• babies with severe congenital anomalies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Blood Transfusion

No Intervention group

Description:

It was planned to transfuse the blood at +4C temperature brought from the blood bank center in 3 hours. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K.

Blood transfusıon

Experimental group

Description:

Blood will be warmed before transfusion. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K.

Treatment:

Procedure: Warmed Blood Transfusion