Evidence map›Paper›PMID 31148155›Full record

ArticleBritish journal of haematology2019

Amustaline-glutathione pathogen-reduced red blood cell concentrates for transfusion-dependent thalassaemia.

Yesim Aydinok, Antonio Piga, Raffaella Origa, Nina Mufti, Anna Erickson, Anne North, Katie Waldhaus, Christine Ernst, Jin-Sying Lin, Norman Huang and 2 more

Abstract read
In one paragraph

Article in British journal of haematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Trial
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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

12 authors.

Yesim AydinokDepartment of Paediatric Haematology and Oncology, Ege University Hospital, Izmir, Turkey.
Antonio PigaDepartment of Clinical and Biological Sciences, University of Turin, Turin, Italy.
Raffaella OrigaOspedale Pediatrico Microcitemico, Universita di Cagliari, Cagliari, Italy.
Nina MuftiCerus Corporation, Concord, CA, USA.
Anna EricksonCerus Corporation, Concord, CA, USA.
Anne NorthCerus Corporation, Concord, CA, USA.
Katie WaldhausCerus Corporation, Concord, CA, USA.
Christine ErnstCerus Corporation, Concord, CA, USA.
Jin-Sying LinCerus Corporation, Concord, CA, USA.
Norman HuangCerus Corporation, Concord, CA, USA.
Richard J BenjaminCerus Corporation, Concord, CA, USA.
Laurence CorashCerus Corporation, Concord, CA, USA.ORCID 0000-0002-8615-9869

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Transfusion-dependent thalassaemia (TDT) requires red blood cell concentrates (RBCC) to prevent complications of anaemia, but carries risk of infection. Pathogen reduction of RBCC offers potential to reduce infectious risk. We evaluated the efficacy and safety of pathogen-reduced (PR) Amustaline-Glutathione (A-GSH) RBCC for TDT. Patients were randomized to a blinded 2-period crossover treatment sequence for six transfusions over 8-10 months with Control and A-GSH-RBCC. The efficacy outcome utilized non-inferiority analysis with 90% power to detect a 15% difference in transfused haemoglobin (Hb), and the safety outcome was the incidence of antibodies to A-GSH-PR-RBCC. By intent to treat (80 patients), 12·5 ± 1·9 RBCC were transfused in each period. Storage durations of A-GSH and C-RBCC were similar (8·9 days). Mean A-GSH-RBCC transfused Hb (g/kg/day) was not inferior to Control (0·113 ± 0·04 vs. 0·111 ± 0·04, P = 0·373, paired t-test). The upper bound of the one-sided 95% confidence interval for the treatment difference from the mixed effects model was 0·005 g/kg/day, within a non-inferiority margin of 0·017 g/kg/day. A-GSH-RBCC mean pre-transfusion Hb levels declined by 6·0 g/l. No antibodies to A-GSH-RBCC were detected, and there were no differences in adverse events. A-GSH-RBCCs offer potential to reduce infectious risk in TDT with a tolerable safety profile.

Indexed as

ErythrocytesAcridinesAdolescentAdultBlood TransfusionChildErythrocyte IndicesFemaleGlutathioneHemoglobinsHumansMaleNitrogen Mustard CompoundsThalassemiaYoung AdultAcridinesGlutathioneHemoglobinsNitrogen Mustard Compounds(N,N-bis(2-chloroethyl))-2-aminoethyl-3-((acridin-9-yl)amino)propionateinfectionironRBCthalassaemiatransfusion

Identifiers

PMID31148155
PMCPMC6771954

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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.