Warmed Blood Transfusion in Premature Infants

NCT06425783 | Active Not Recruiting

• 1 other identifier: SYNEO-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion Related Complication; Premature

Keywords

premature infants; warmed blood transfusion; hypothermia; hemolysis

Outcome Measures

Primary Outcomes (3)

• Effect of heated blood transfusion on body temperature in premature babies

  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.

  6 hours

• Effects of warming blood in blood transfusion on cerebral tissue oxygenation

  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.

  8 hours

• Effect of heated and unheated blood transfusion on hematocrit level

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

  8 hours

Secondary Outcomes (3)

• Effect of warming blood on potassium level

  6 hours

• Effect of warming blood on LDH level

  6 hours

• Effect of heated blood on blood lactate level

  8 hours

Study Arms (2)

Blood Transfusion

NO INTERVENTION

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

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.

Procedure: Warmed Blood Transfusion

Interventions

Warmed Blood Transfusion PROCEDURE

The erythrocyte suspension will be heated between 34-36 C⁰, which is the determined physiological temperature. 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. 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

Eligibility Criteria

• Age: 1 Hour - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• babies with severe congenital anomalies

Sponsors & Collaborators

• Goztepe Prof Dr Suleyman Yalcın City Hospital: lead

Study Sites (1)

Goztepe Prof Dr. Suleyman Yalcın City Hospital

Istanbul, N/A (n/a), 34730, Turkey (Türkiye)

Location

Related Publications (4)

• Bailey SM, Mally PV. Near-Infrared Spectroscopy to Guide and Understand Effects of Red Blood Cell Transfusion. Clin Perinatol. 2023 Dec;50(4):895-910. doi: 10.1016/j.clp.2023.07.006. Epub 2023 Aug 17.

  PMID: 37866855 BACKGROUND

• Poder TG, Nonkani WG, Tsakeu Leponkouo E. Blood Warming and Hemolysis: A Systematic Review With Meta-Analysis. Transfus Med Rev. 2015 Jul;29(3):172-80. doi: 10.1016/j.tmrv.2015.03.002. Epub 2015 Mar 24.

  PMID: 25840802 RESULT

• Hulse W, Bahr TM, Fredrickson L, Canfield CM, Friddle K, Pysher TJ, Ilstrup SJ, Ohls RK, Christensen RD. Warming blood products for transfusion to neonates: In vitro assessments. Transfusion. 2020 Sep;60(9):1924-1928. doi: 10.1111/trf.16007. Epub 2020 Aug 10.

  PMID: 32776545 RESULT

• Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22.

  PMID: 20113454 RESULT

MeSH Terms

Conditions

Premature Birth; Hypothermia; Hemolysis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Fahri Ovalı, Prof

  Istanbul Medeniyet University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric clinic chief assistant, MD

Model Details: randomized controlled, parallel group. A single center

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 22, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)