Evidence map›Paper›PMID 39719927›Full record

Trial reportTransfusion2025

Characterizing the antibody response to amustaline/glutathione pathogen-reduced red blood cells.

Christopher Karim, Anil Panigrahi, Ronald G Pearl, Neel R Sodha, Thomas M Beaver, J Peter R Pelletier, Gregory A Nuttall, T Brett Reece, Anna Erickson, Teresa Hedrick and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Transfusion, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03459287 (A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures), which is not on this 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.

NCT03459287 phase3completednot on this map

A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures

TypeinterventionalSponsorCerus CorporationRan2018 to 2024Enrolled581ConditionsAnemiaArmsINTERCEPT, Control
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. 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

16 authors.

Christopher KarimCerus Corporation, Concord, California, USA.
Anil PanigrahiStanford University, Stanford, California, USA.
Ronald G PearlStanford University, Stanford, California, USA.
Neel R SodhaRhode Island Hospital, Providence, Rhode Island, USA.
Thomas M BeaverUniversity of Florida, Gainesville, Florida, USA.
J Peter R PelletierUniversity of Florida, Gainesville, Florida, USA.
Gregory A NuttallMayo Clinic, Rochester, Minnesota, USA.
T Brett ReeceUniversity of Colorado Hospital, Denver, Colorado, USA.
Anna EricksonCerus Corporation, Concord, California, USA.
Teresa HedrickCerus Corporation, Concord, California, USA.
Kathy LiuCerus Corporation, Concord, California, USA.
Stanley BentowCerus Corporation, Concord, California, USA.
Laurence CorashCerus Corporation, Concord, California, USA.ORCID https://orcid.org/0000-0002-8615-9869
Nina MuftiCerus Corporation, Concord, California, USA.
Jeanne VarroneCerus Corporation, Concord, California, USA.
Richard J BenjaminCerus Corporation, Concord, California, USA.ORCID https://orcid.org/0000-0001-6618-4744

Funding

Biomedical Advanced Research and Development Authority HHS010020160009c
6 · The paper itself

Abstract

backgroundThe clinical significance of natural and treatment-emergent antibodies specific for amustaline/glutathione pathogen-reduced red blood cells (PRRBCs) is not known. STUDY DESIGN AND

methodsA Phase 3, randomized clinical trial of PRRBCs (ReCePI) compared PRRBCs with conventional RBCs in cardiac or thoracic-aorta surgery. Subjects transfused during and for 7 days after surgery were screened for PRRBC-specific antibodies at baseline, 28 and 75 days post-surgery. Subjects with treatment-emergent antibodies were assessed for evidence of hemolysis. Cryopreserved subject RBC samples were assayed by flow cytometry for circulating PRRBCs using an acridine-specific (2S197-2M1) monoclonal antibody, and for human IgG-coated RBCs. RBC-surface acridine density was quantitated using a commercial calibrated phycoerythrin (PE)-bead panel.

resultsFive of 159 (3.1%) PRRBC and zero of 162 conventional RBC recipients developed treatment-emergent PRRBC-specific IgG, low titer antibodies detected 26-80 days post-surgery after exposure to 1-3 PRRBC units, without clinical evidence of hemolysis. DAT and eluate were weak (w+) positive and PRRBC-specific in one subject. A monocyte monolayer assay (MMA) was non-reactive in the three subjects with an interpretable result. Flow cytometry demonstrated circulating PRRBCs in all five subjects expressing surface acridine concentrations at the limit of detection (approximately 150-301 PE molecules/RBC) compared with freshly transfused PRRBCs (approximately 7500 PE molecules/RBC). In some samples, loss of surface acridine expression could not be distinguished from clearance of the PRRBCs. DISCUSSION: Treatment-emergent PRRBC-specific antibodies with the characteristics of nonclinically significant antibodies were detected in five subjects transfused with PRRBCs. Flow cytometry demonstrated persistent circulating PRRBCs with minimal surface acridine expression. (www. CLINICALTRIALS: gov Identifier NCT03459287).

Indexed as

ErythrocytesErythrocyte TransfusionGlutathioneAdultAgedFemaleFlow CytometryHumansImmunoglobulin GMaleMiddle AgedGlutathioneImmunoglobulin Gantibodiespathogen reductionRBCs

Identifiers

PMID39719927
PMCPMC11826292

What OpenQuestion holds

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Registered trials

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.