Transfusion Related ComplicationNCT06425783
Warmed Blood Transfusion in Premature Infants
A study testing Warmed Blood Transfusion in people with Transfusion Related Complication and Premature, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 3 months
- Conditions the study is for
- Transfusion Related Complication, Premature
- What is being tested?
- Warmed Blood Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature babies less than 34 weeks of gestation Babies requiring ES transfusions while receiving treatment in the NICU
Who cannot join
- babies with severe congenital anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Prof Dr. Suleyman Yalcın City Hospital
Istanbul, N/A (n/a), 34730
About this study
Official title: Warmed Blood Transfusion in Premature Babies Less Than 34 Weeks of Gestational Age: a Randomized Controlled Trial
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.
Read the 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:
- 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.
- 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.
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
- Conditions
- Transfusion Related Complication, Premature
- Being tested
- Warmed Blood Transfusion
- Keywords
- premature infants, warmed blood transfusion, hypothermia, hemolysis
- Medical subject headings
- Premature Birth, Hypothermia, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed Blood TransfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Warmed Blood Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 hours
Secondary outcomes (3)
Effect of warming blood on potassium level
After the blood is brought to physiological body temperature, a sample will be taken before giving it to the baby. The presence of hemolysis will be evaluated by measuring the potassium level in blood heated at 34-36 C. At the end of the blood transfusion, potassium will be measured in the blood taken from the baby.
Measured: 6 hours
Effect of warming blood on LDH level
After blood transfusion, LDH will be measured by taking blood samples from the babies in both groups. A measurement of LDH above 700 will be defined as hemolysis.
Measured: 6 hours
Effect of heated blood on blood lactate level
At the end of heated and unheated blood transfusion, blood gas and blood lactate levels will be measured. It will be compared which transfusion application increases the lactate level more.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Apr 2024
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transfusion Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled, parallel group. A single center
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Sevuk Ozumut, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Fahri Ovalı, Prof, Study chair, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425783
- Sponsor's protocol ID
- SYNEO-03
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37866855Poder 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.
PubMed 25840802Hulse 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.
PubMed 32776545Dani 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.
PubMed 20113454
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warmed Blood Transfusion in Premature Babies Less Than 34 Weeks of Gestational Age: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06425783
- Acronym / sponsor ID
- SYNEO-03
- Conditions
- Transfusion Related Complication, Premature
- Keywords
- premature infants, warmed blood transfusion, hypothermia, hemolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized controlled, parallel group. A single center
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Warmed Blood TransfusionBlood 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. |
Who may qualify
- Ages
- 1 hour to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature babies less than 34 weeks of gestation Babies requiring ES transfusions while receiving treatment in the NICU
Key exclusion criteria (1 listed)
- babies with severe congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warmed Blood TransfusionThe 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. | Procedure or surgery | Blood transfusıon |
Primary outcome
Effect of heated blood transfusion on body temperature in premature babies
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Effect of warming blood on potassium level
Time frame: 6 hours
Effect of warming blood on LDH level
Time frame: 6 hours
Effect of heated blood on blood lactate level
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 37866855Bailey 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.
- Results publication: PubMed 25840802Poder 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.
- Results publication: PubMed 32776545Hulse 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.
- Results publication: PubMed 20113454Dani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahri Ovalı, Prof study chair
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warmed Blood Transfusion in people with Transfusion Related Complication and Premature, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of heated blood transfusion on body temperature in premature babies (time frame: 6 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425783, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.