Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425783
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-08
Brief Title:
Warmed Blood Transfusion in Premature Infants
Sponsor:
Goztepe Prof Dr Suleyman Yalcın City Hospital
Organization:
Goztepe Prof Dr Suleyman Yalcın City Hospital
Study Overview
Official Title:
Warmed Blood Transfusion in Premature Babies Less Than 34 Weeks of Gestational Age a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed 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 mlkg 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
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 mlkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None