Clinical evaluation of red cell concentrates in non‐DEHP plasticized containers compared with standard DEHP plasticized containers: A quasi‐randomized observational multicentre study

• DOI: 10.1111/vox.70019
• Publication Date: 2025-03-27T00:37:22Z
• Authors: Christie Vermeulen; Nan van Geloven; Bart Mertens; Saskia E. Spelmink; Martin R. Schipperus; Mart P. Janssen; Jean‐Louis H. Ker...; Gijs den Besten; Annegeet G. van d...; Irene M. L. W. Kö...; Daan van de Kerkhof; Harriët J. H. Kli...; Karen M. K. De Vo...; Adriaan J. van Ga...; Henk Russcher; Josephine W. M. H...; Dirk de Korte; Pieter F. van der...; Thomas R. L. Klei

AbstractBackground and ObjectivesThe 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 MethodsA 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.ResultsA 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).ConclusionAn 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.