We previously developed and published a novel device to automate double volume exchange transfusions (DVET) via the umbilical venous catheter (UVC) in neonates. Prior to initiating clinical trials, we aimed to demonstrate that alterations in blood composition after passage through our device’s circuit were not greater than those seen with the conventional manual method. We performed five ex vivo simulations of neonatal DVET using donor blood in standard blood bank bags and our automated device. Samples were obtained from the blood bag at baseline and from the distal end of the circuit after completion of 50% and 100% of the simulated DVET. These were analyzed for hematological, biochemical, and blood gas parameters, osmolality, and culture. For comparison, four manual DVETs were similarly performed, with corresponding sample collection and analyses. Deviations of laboratory parameters at the 50% and 100% time points that were > ± 25% from baseline were classified as major. The proportion of major deviations was compared between automated and manual DVETs. Automated DVETs demonstrated significantly fewer major deviations than manual DVETs in hematological parameters [15/156 (9.61%) vs. 28/124 (22.58%), p = 0.0048], biochemical parameters [0/120 (0%) vs. 32/88 (36.36%), p < 0.0001], and blood gas values [11/50 (22.0%) vs. 20/40 (50.0%), p = 0.011]. Notably, the blood used in automated DVETs was significantly older than that used in the manual group. Conclusion: Automated DVET using our novel device results in fewer compositional deviations from baseline compared to conventional manual DVET, supporting its potential clinical utility.<Table Float="No" ID="Taba"> <tgroup cols="1"> <colspec align="left" colname="c1" colnum="1" /> <tbody> <row> <entry align="left" colname="c1"> What is Known: • Our research group previously developed and published a novel electromechanical device to perform double volume exchange transfusions (DVET) in neonates through the umbilical venous route. • Previous authors who had made automated devices did not analyze the composition of the blood exiting the device circuit (“post-circuit” composition), nor compared this to the conventional manual method of exchange transfusions. </entry> </row> <row> <entry align="left" colname="c1"> What is New: • In simulated DVETs performed with our device, there were significantly fewer changes in the post-circuit composition of the blood from baseline (hematological, biochemical, blood gas and osmolality values) compared to manual DVETs. • Among DVETs performed manually, 7 ml aliquots per cycle were associated with greater changes in the post-circuit composition of the blood compared to 10 ml aliquots per cycle. </entry> </row> </tbody> </tgroup> </Table>

Change in composition of blood after passing through circuit of automated device versus manual clinical method for neonatal exchange transfusions

期刊论文
发表日期：

2025年12月22日

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Sourabh Dutta,
Neha Sharma,
Suchet Sachdev,
Ratti Ram Sharma,
Sanjeev Verma,
Arindam Chatterjee,
Prateek Bhatia,
Savita Attri,
Archana Angrup,
Sarbjeet Singh,
Gurinderjit Singh,
Praveen Kumar

摘要

We previously developed and published a novel device to automate double volume exchange transfusions (DVET) via the umbilical venous catheter (UVC) in neonates. Prior to initiating clinical trials, we aimed to demonstrate that alterations in blood composition after passage through our device’s circuit were not greater than those seen with the conventional manual method. We performed five ex vivo simulations of neonatal DVET using donor blood in standard blood bank bags and our automated device. Samples were obtained from the blood bag at baseline and from the distal end of the circuit after completion of 50% and 100% of the simulated DVET. These were analyzed for hematological, biochemical, and blood gas parameters, osmolality, and culture. For comparison, four manual DVETs were similarly performed, with corresponding sample collection and analyses. Deviations of laboratory parameters at the 50% and 100% time points that were > ± 25% from baseline were classified as major. The proportion of major deviations was compared between automated and manual DVETs. Automated DVETs demonstrated significantly fewer major deviations than manual DVETs in hematological parameters [15/156 (9.61%) vs. 28/124 (22.58%), p = 0.0048], biochemical parameters [0/120 (0%) vs. 32/88 (36.36%), p < 0.0001], and blood gas values [11/50 (22.0%) vs. 20/40 (50.0%), p = 0.011]. Notably, the blood used in automated DVETs was significantly older than that used in the manual group.

Conclusion: Automated DVET using our novel device results in fewer compositional deviations from baseline compared to conventional manual DVET, supporting its potential clinical utility.

What is Known:

• Our research group previously developed and published a novel electromechanical device to perform double volume exchange transfusions (DVET) in neonates through the umbilical venous route.

• Previous authors who had made automated devices did not analyze the composition of the blood exiting the device circuit (“post-circuit” composition), nor compared this to the conventional manual method of exchange transfusions.

What is New:

• In simulated DVETs performed with our device, there were significantly fewer changes in the post-circuit composition of the blood from baseline (hematological, biochemical, blood gas and osmolality values) compared to manual DVETs.

• Among DVETs performed manually, 7 ml aliquots per cycle were associated with greater changes in the post-circuit composition of the blood compared to 10 ml aliquots per cycle.