Postprint online available 10/2019 Open Access Green as soon as is submitted to ZB.
Blood draws up to 3% of blood volume in clinical trials are safe in children.
Acta Paediatr. 108, 940-944 (2019)
Aim Recommendations for maximum blood draw in children range from 1 to 5% despite limited evidence. The aim of the study was to assess the safety of blood draws in children aged six months to 12 years targeting volumes of 3% of total blood volume. Methods Children who experienced three-monthly blood draws during participation in one of three investigators initiated clinical trials conducted in our institution were examined. In total, 629 venous blood draws were performed in 141 children. Adverse events and blood counts were assessed. Results Overall, 608 adverse events were reported. None of these included symptoms that reflected concerns on blood draw volumes or frequency. Anaemia and red cell or haemoglobin measurements outside the normal age range were not observed. A reduction in haemoglobin, haematocrit, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration and mean corpuscular volume was noted in children participating in one of the three trials analysed. Conclusion Regular blood draws of up to 3% of total blood volume were not associated with signs of anaemia or hypovolaemia in young children. We suggest that the European recommendations be revised for clinical studies in which children are not exposed to treatments that are associated with anaemia risk.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Blood Collection ; Blood Draw Safety In Children ; Paediatric Research ; Safe Phlebotomy ; Single Blood Draw
Institute(s) Institute of Diabetes Research Type 1 (IDF)