TY - JOUR
T1 - Clinical evaluation of red cell concentrates in non-DEHP plasticized containers compared with standard DEHP plasticized containers
T2 - A quasi-randomized observational multicentre study
AU - Vermeulen, Christie
AU - van Geloven, Nan
AU - Mertens, Bart
AU - Spelmink, Saskia E
AU - Schipperus, Martin R
AU - Janssen, Mart P
AU - Kerkhoffs, Jean-Louis H
AU - den Besten, Gijs
AU - van den Bos, Annegeet G
AU - Körver-Keularts, Irene M L W
AU - van de Kerkhof, Daan
AU - Klinkspoor, Harriët J H
AU - De Vooght, Karen M K
AU - van Gammeren, Adriaan J
AU - Russcher, Henk
AU - Heijnen, Josephine W M
AU - de Korte, Dirk
AU - van der Meer, Pieter F
AU - Klei, Thomas R L
N1 - Publisher Copyright:
© 2025 International Society of Blood Transfusion.
PY - 2025/11
Y1 - 2025/11
N2 - BACKGROUND AND OBJECTIVES: The use of di-ethyl-hexyl-phthalate (DEHP) in medical devices will be banned in the European Union from 1 July 2030, onwards. It is therefore important to evaluate the performance of non-DEHP blood collection system alternatives. Previously, we reported that red cell concentrates (RCCs) in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) stored in non-DEHP blood containers did not result in an increased transfusion reaction rate (TRR) as compared with saline-adenine-glucose-mannitol (SAGM)/DEHP-stored RCC. The current study aimed to extend the dataset and confirm previous findings.MATERIALS AND METHODS: A quasi-randomized observational study was conducted to compare the number and type of transfusion reactions. A 95% credibility interval for the TRR odds ratio (OR) was calculated.RESULTS: A total of 7507 BTHC/PAGGSM and 25,371 DEHP/SAGM RCCs were transfused, yielding a TRR of 0.35% (0.22%-0.49%) and 0.20% (0.15%-0.26%), respectively, with an OR of 1.76 (1.10-2.81). Pooling data of the current and previous study resulted in an OR of 1.36 (0.90-2.08). Restricting the pooled data to imputability categories 'possible', 'probable' and 'definite' yielded an OR of 1.09 (0.66-1.81).CONCLUSION: An increased TRR was observed for BTHC/PAGGSM in the new dataset, though it was still consistent with those of DEHP when aggregating data from both studies.
AB - BACKGROUND AND OBJECTIVES: The use of di-ethyl-hexyl-phthalate (DEHP) in medical devices will be banned in the European Union from 1 July 2030, onwards. It is therefore important to evaluate the performance of non-DEHP blood collection system alternatives. Previously, we reported that red cell concentrates (RCCs) in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) stored in non-DEHP blood containers did not result in an increased transfusion reaction rate (TRR) as compared with saline-adenine-glucose-mannitol (SAGM)/DEHP-stored RCC. The current study aimed to extend the dataset and confirm previous findings.MATERIALS AND METHODS: A quasi-randomized observational study was conducted to compare the number and type of transfusion reactions. A 95% credibility interval for the TRR odds ratio (OR) was calculated.RESULTS: A total of 7507 BTHC/PAGGSM and 25,371 DEHP/SAGM RCCs were transfused, yielding a TRR of 0.35% (0.22%-0.49%) and 0.20% (0.15%-0.26%), respectively, with an OR of 1.76 (1.10-2.81). Pooling data of the current and previous study resulted in an OR of 1.36 (0.90-2.08). Restricting the pooled data to imputability categories 'possible', 'probable' and 'definite' yielded an OR of 1.09 (0.66-1.81).CONCLUSION: An increased TRR was observed for BTHC/PAGGSM in the new dataset, though it was still consistent with those of DEHP when aggregating data from both studies.
KW - non-DEHP blood containers
KW - red cell concentrates
KW - transfusion reactions
UR - https://www.scopus.com/pages/publications/105000651659
U2 - 10.1111/vox.70019
DO - 10.1111/vox.70019
M3 - Article
C2 - 40129135
SN - 0042-9007
VL - 120
SP - 1183
EP - 1188
JO - Vox Sanguinis
JF - Vox Sanguinis
IS - 11
ER -