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

Author:

Lewis Anna Elisabet12,Kappel Susanne S.13ORCID,Hussain Samya1,Sangild Per T.134,Zachariassen Gitte45ORCID,Aunsholt Lise136

Affiliation:

1. Comparative Pediatrics and Nutrition University of Copenhagen Copenhagen Denmark

2. Department of Neonatology Nordsjællands Hospital Hillerød Denmark

3. Department of Neonatology Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

4. Hans Christian Andersen Children's Hospital Odense University Hospital Odense Denmark

5. Department of Clinical Research University of Southern Denmark Odense Denmark

6. Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Abstract

AbstractAimTo 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.MethodsFor 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.ResultsMean (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).ConclusionClinical 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.

Publisher

Wiley

Subject

General Medicine,Pediatrics, Perinatology and Child Health

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