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

Abstract

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.