Blood draws up to 3% of blood volume in clinical trials are safe in children

التفاصيل البيبلوغرافية
العنوان: Blood draws up to 3% of blood volume in clinical trials are safe in children
المؤلفون: Claudia Peplow, Anette-G. Ziegler, Joerg Hasford, Andreas Beyerlein, Ezio Bonifacio, Robin Assfalg
المصدر: Acta Paediatrica (Oslo, Norway : 1992)
Acta Paediatr. 108, 940-944 (2019)
سنة النشر: 2018
مصطلحات موضوعية: Male, Blood collection, Pediatrics, medicine.medical_specialty, Safe phlebotomy, Blood Sampling, Blood volume, Paediatric research, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Clinical Protocols, Phlebotomy, 030225 pediatrics, Blood Collection, Blood Draw Safety In Children, Paediatric Research, Safe Phlebotomy, Single Blood Draw, medicine, Humans, 030212 general & internal medicine, Limited evidence, Adverse effect, Child, Mean corpuscular volume, Clinical Trials as Topic, Blood Volume, medicine.diagnostic_test, business.industry, Patient Selection, Age Factors, Blood draw safety in children, Regular Article, General Medicine, Venous blood, ddc, Single blood draw, Clinical trial, Blood draw, Child, Preschool, Pediatrics, Perinatology and Child Health, Female, business, Blood drawing, Regular Articles
الوصف: 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.
وصف الملف: application/pdf; application/msword
تدمد: 1651-2227
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5ef6c2a1bc40eb7e820b947ccc023cb6
https://pubmed.ncbi.nlm.nih.gov/30291644
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....5ef6c2a1bc40eb7e820b947ccc023cb6
قاعدة البيانات: OpenAIRE