Trial-related blood sampling and red-blood-cell transfusions in preterm infants

Anna Elisabet Lewis, Susanne S Kappel, Samya Hussain, Per T Sangild, Gitte Zachariassen, Lise Aunsholt*

*Corresponding author af dette arbejde
2 Citationer (Scopus)

Abstract

AIM: To determine if trial-related blood sampling increases the risk of later red blood cell (RBC) transfusion in very preterm infants, we compared the volume of clinical- and trial-related blood samples, in a specific trial and correlated to subsequent RBC transfusion.

METHODS: For 193 very preterm infants, participating in the FortiColos trial (NCT03537365), trial-related blood volume drawn was in accordance with ethical considerations established by the European Commission. Medical records were reviewed to assess the number and accumulated volume (mL/kg) of blood samples (both clinical- and trial-related). Data were compared with the need of RBC transfusions during the first 28 days of life.

RESULTS: Mean (SD) gestational age and birth weight was 28 ± 1 weeks and 1168 ± 301 g. In total, 11% of total blood volume was drawn for sampling (8.1 ± 5.1 mL/kg) and trial-related sampling accounted for 1.6 ± 0.6 mL/kg. Trial-related blood sampling had no impact on RBC transfusion (p = 0.9).

CONCLUSION: Clinical blood sampling in very preterm infants is associated with blood loss and subsequent need for RBC transfusions. In a specific trial requiring blood samples, we found no additional burden of trial-related blood sampling. The study suggests that trial-related sampling is safe if European criteria are followed.

OriginalsprogEngelsk
TidsskriftActa paediatrica
Vol/bind112
Udgave nummer12
Sider (fra-til)2486-2492
Antal sider7
ISSN1651-2227
DOI
StatusUdgivet - dec. 2023

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