Evidence map›Paper›PMID 39243178›Full record

Trial reportTransfusion medicine (Oxford, England)2025

An evaluation of diethylhexyl phthalate free top & bottom in-line blood collection set with a new soft housing filter.

Elena Danilova, Farshid Ezligini, Connie Stöckel, Masafumi Asakawa, Geir Hetland

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Transfusion medicine (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Elena DanilovaDepartment of Immunology, Oslo University Hospital, Oslo, Norway.ORCID https://orcid.org/0000-0003-1689-7628
Farshid EzliginiDepartment of Immunology, Oslo University Hospital, Oslo, Norway.
Connie StöckelAsahi Kasei Medical Europe GmbH, Asahi Kasei Medical Co., Ltd., Chiyoda, Japan.
Masafumi AsakawaMarketing & Sales Department, Sepacell Division, Asahi Kasei Medical Co., Ltd., Chiyoda, Japan.
Geir HetlandDepartment of Immunology, Oslo University Hospital, Oslo, Norway.

Funding

Asahi Kasei Medical Co., Ltd
6 · The paper itself

Abstract

BACKGROUND AND

objectivesDi (2-ethylhexyl) phthalate (DEHP) plasticizer must be removed from polyvinylchloride (PVC) medical devices due to toxicity. DEHP/PVC blood bags were shown to provide stable quality under blood component production and to create good storage conditions for red blood cells concentrate (RBC). It is important that substitution of the DEHP maintains the RBC quality during storage, which should be achieved with Di (isononyl) cyclohexane-1,2-dicarboxylate (DINCH), although substitution of the plasticizer has been challenging. MATERIALS AND

methodsA DEHP-free Top & Bottom in-line RBC set was validated in a tertiary hospital blood bank facility. Volunteer blood donors were randomly allocated for blood collection into DINCH/PVC or DEHP/PVC set. The groups were additionally divided according to additive solution/filter combination: PAGGS-M + DINCH/PVC filter (only with DINCH/PVC set), and SAG-M + DINCH/PVC filter and SAG-M + DEHP/PVC filter (only with DEHP/PVC set). Processing and storage effects were assessed in all components.

resultsRBC concentrates, platelet concentrates and plasma that was processed and stored in DEHP-free set fulfilled European requirements for quality. The cells stored in PAGGS-M after filtration through DEHP-free PVC filter showed the same low haemolysis compared with conventional set at 49 days of storage. Platelets stored in DINCH/PVC bag provided a sufficient quality of platelets after 7 days of storage. Plasma maintained the coagulation factors during 12 months of storage.

conclusionA new DINCH/PVC set allows production of blood components of satisfactory quality in DEHP-free environment.

Indexed as

Blood PreservationBlood Specimen CollectionDiethylhexyl PhthalateErythrocytesFiltrationPlasticizersAdultCyclohexanecarboxylic AcidsDicarboxylic AcidsFemaleHumansMalePolyvinyl ChlorideCyclohexanecarboxylic AcidsDicarboxylic AcidsDiethylhexyl Phthalatediisononyl 1,2-cyclohexanedicarboxylic acidPlasticizersPolyvinyl ChlorideDINCHphthalate freeplasmaplasticizerplateletsred blood cells

Identifiers

PMID39243178
PMCPMC11833214

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.