Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

Erythrocyte Transfusion Clinical Trial

Official title:

Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983694
• Other study ID #: BabyLux transfusion
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The timing and the indications for red blood cell (RBC) transfusions remain one of the most controversial topic in Neonatology. Indeed, biomarkers routinely used to discriminate between patients that will benefit from RBC transfusion appear insufficient. Tissue oxygenation could be useful to determine the need for transfusion.

This study aims to assess the effects of RBC transfusion on cerebral haemodynamics and oxygenation in neonates with a new hybrid optical device (BabyLux) integrating time-resolved spectroscopy (NIRS-TRS) and diffuse correlation spectroscopy (DCS).

It is hypothesized that cerebral blood flow decreases after RBC transfusion, whereas cerebral oxygenation and oxygen metabolism are unchanged.

Description:

The BabyLux hybrid setup can determine the following parameters in the same tissue sample non-invasively and continuously with a high temporal resolution (0.1-0.2 Hz):

• Cerebral blood flow index (CBFi), i.e. an index that is proportional with CBF

• Concentration of oxyhaemoglobin (O2Hb)

• Concentration of deoxyhaemoglobin (dHb)

• Total haemoglobin concentration (tHb)

• Tissue oxygen saturation (rStO2)

• Cerebral metabolic rate of oxygen index (CMRO2i), i.e. an index that is proportional with CMRO2 Hence, the BabyLux device allows assessment of key parameters of cerebral haemodynamics and, in particular, to examine if the percentage change of cerebral metabolic rate for oxygen is close to the expected zero, as an external quality control of the separate NIRS parameters.

There are no studies on RBC transfusion in neonates evaluating cerebral haemodynamic utilizing DCS and TRS combined.

Hence, primary aim of this study is:

• to assess the effect of RBC transfusion on cerebral haemodynamics and oxygenation as measured by the Babylux device.

Secondary aims are:

• to quantify the effect of estimated ∆[Hb] on the differential path length factor (DPF);

• to compare two different NIRS devices and techniques. BabyLux measurement will be performed before and after RBC transfusion, whereas during RBC transfusion cerebral oxygenation will be monitored with a spatially resolved continuous wave (CW) NIRS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 20, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Weeks to 4 Weeks

Eligibility

Inclusion Criteria:

• RBC transfusion prescribed according to local NICU guidelines

• Corrected age < 4 weeks corrected age

• Signed informed consent

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Cerebral Haemodynamics
• Erythrocyte Transfusion

Intervention

Other:
• Erythrocyte transfusion
The cerebro-vascular effects of a clinically prescribed erytrocyte (red blood cell) transfusion is examined. Before the transfusion, BabyLux sensor is placed on the neonatal fronto-parietal region and held in place by a self-adhesive bandage. A baseline prior to transfusion is established through a series of five repeated measurements of 1 minute taken during a stable period just before the transfusion is started. Once transfusion has ended, another series of five repeated measurements of 1 minute taken during a stable period are performed to determine the responses. Cerebral oxygenation as determined by a commercial spatially resolved NIRS device with neonatal sensor will be continuously recorded during transfusion.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Gorm Greisen	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Bailey SM, Hendricks-Munoz KD, Wells JT, Mally P. Packed red blood cell transfusion increases regional cerebral and splanchnic tissue oxygen saturation in anemic symptomatic preterm infants. Am J Perinatol. 2010 Jun;27(6):445-53. doi: 10.1055/s-0030-1247598. Epub 2010 Jan 22. — View Citation

Banerjee J, Aladangady N. Biomarkers to decide red blood cell transfusion in newborn infants. Transfusion. 2014 Oct;54(10):2574-82. doi: 10.1111/trf.12670. Epub 2014 May 5. — View Citation

Cerussi A, Van Woerkom R, Waffarn F, Tromberg B. Noninvasive monitoring of red blood cell transfusion in very low birthweight infants using diffuse optical spectroscopy. J Biomed Opt. 2005 Sep-Oct;10(5):051401. doi: 10.1117/1.2080102. — View Citation

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. — View Citation

Koyano K, Kusaka T, Nakamura S, Nakamura M, Konishi Y, Miki T, Ueno M, Yasuda S, Okada H, Nishida T, Isobe K, Itoh S. The effect of blood transfusion on cerebral hemodynamics in preterm infants. Transfusion. 2013 Jul;53(7):1459-67. doi: 10.1111/j.1537-2995.2012.03953.x. Epub 2012 Nov 12. — View Citation

Sandal G, Oguz SS, Erdeve O, Akar M, Uras N, Dilmen U. Assessment of red blood cell transfusion and transfusion duration on cerebral and mesenteric oxygenation using near-infrared spectroscopy in preterm infants with symptomatic anemia. Transfusion. 2014 Apr;54(4):1100-5. doi: 10.1111/trf.12359. Epub 2013 Jul 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral metabolic rate of oxygen index (CMRO2i)	The change in an index proportional to CMRO2	From immediately before to immediately after RBC transfusion
Secondary	Tissue oxygen saturation (rStO2)	The change in oxygenated haemoglobin/total haemoglobin	From immediately before to immediately after RBC transfusion
Secondary	Cerebral blood flow index (CBFi)	The change in an index proportional to CBF	From immediately before to immediately after RBC transfusion
Secondary	Differential path length factor (DPF)	The change in an optical parameter for physiological measurement using NIRS	From immediately before to immediately after RBC transfusion

External Links

•   The BabyLux project web-site