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

IF 1.8 4区医学 Q3 HEMATOLOGY

Vox Sanguinis Pub Date : 2025-03-24 DOI:10.1111/vox.70019

Christie Vermeulen, Nan van Geloven, Bart Mertens, Saskia E Spelmink, Martin R Schipperus, Mart P Janssen, Jean-Louis H Kerkhoffs, Gijs den Besten, Annegeet G van den Bos, Irene M L W Körver-Keularts, Daan van de Kerkhof, Harriët J H Klinkspoor, Karen M K De Vooght, Adriaan J van Gammeren, Henk Russcher, Josephine W M Heijnen, Dirk de Korte, Pieter F van der Meer, Thomas R L Klei

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引用次数: 0

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.

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来源期刊

Vox Sanguinis 医学-血液学

CiteScore

4.40

自引率

11.10%

发文量

156

审稿时长

6-12 weeks

期刊介绍： Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections: 1) Transfusion - Transmitted Disease and its Prevention: Identification and epidemiology of infectious agents transmissible by blood; Bacterial contamination of blood components; Donor recruitment and selection methods; Pathogen inactivation. 2) Blood Component Collection and Production: Blood collection methods and devices (including apheresis); Plasma fractionation techniques and plasma derivatives; Preparation of labile blood components; Inventory management; Hematopoietic progenitor cell collection and storage; Collection and storage of tissues; Quality management and good manufacturing practice; Automation and information technology. 3) Transfusion Medicine and New Therapies: Transfusion thresholds and audits; Haemovigilance; Clinical trials regarding appropriate haemotherapy; Non-infectious adverse affects of transfusion; Therapeutic apheresis; Support of transplant patients; Gene therapy and immunotherapy. 4) Immunohaematology and Immunogenetics: Autoimmunity in haematology; Alloimmunity of blood; Pre-transfusion testing; Immunodiagnostics; Immunobiology; Complement in immunohaematology; Blood typing reagents; Genetic markers of blood cells and serum proteins: polymorphisms and function; Genetic markers and disease; Parentage testing and forensic immunohaematology. 5) Cellular Therapy: Cell-based therapies; Stem cell sources; Stem cell processing and storage; Stem cell products; Stem cell plasticity; Regenerative medicine with cells; Cellular immunotherapy; Molecular therapy; Gene therapy.