Evidence map›Paper›PMID 34791571›Full record

Trial reportNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2022

Plasma exchange with albumin replacement and disease progression in amyotrophic lateral sclerosis: a pilot study.

Mónica Povedano, Andrés Paipa, Miquel Barceló, Michael K Woodward, Sandra Ortega, Raúl Domínguez, Maria Esperança Aragonés, Raquel Horrillo, Montserrat Costa, Antonio Páez

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02479802 (Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 37% of its field
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.

NCT02479802 phase2completednot on this map

Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis

TypeinterventionalSponsorInstituto Grifols, S.A.Ran2014 to 2016Enrolled13ConditionsAmyotrophic Lateral SclerosisArmsAlbumin
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

10 authors at 3 institutions in 1 country.

Mónica PovedanoDepartment of Neurology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. mpovedano@bellvitgehospital.cat.
Andrés PaipaDepartment of Neurology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
Miquel BarcelóGrifols Bioscience Research Group, Grifols, Barcelona, Spain.
Michael K WoodwardGrifols Bioscience Research Group, Grifols, Barcelona, Spain.
Sandra OrtegaDepartment of Apheresis, Banc de Sang i Teixits, Barcelona, Spain.
Raúl DomínguezDepartment of Neurology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
Maria Esperança AragonésGrifols Bioscience Research Group, Grifols, Barcelona, Spain.
Raquel HorrilloGrifols Bioscience Research Group, Grifols, Barcelona, Spain.
Montserrat CostaGrifols Bioscience Research Group, Grifols, Barcelona, Spain.
Antonio PáezGrifols Bioscience Research Group, Grifols, Barcelona, Spain.
Grifols (Spain) · ESBellvitge University Hospital · ESBanc de Sang i Teixits · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlasma exchange (PE) is used to treat a range of neurological disorders. Based on results demonstrated in Alzheimer's disease, we theorized that PE with albumin replacement (PE-A) might alter the metabolic profile of plasma and cerebrospinal fluid in patients with amyotrophic lateral sclerosis (ALS) by removing disease-inducing molecules. The aim of this study was to evaluate the effect of PE-A on disease progression in ALS.

methodsIn this open-label, non-controlled, single-arm, prospective pilot study, 13 adults with ALS had 6 months' treatment with PE-A 5% and 6 months' follow-up. Primary endpoints were changes from baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score and forced vital capacity (FVC) through 48 weeks. A post hoc analysis compared individual patient data with the expected ALSFRS-R progression slope.

resultsThe median ALSFRS-R score declined throughout the study, although the rate of decline was slower than expected in seven patients at treatment end and in five patients at study end. Six patients remained in the same baseline slope progression category, and four patients improved their slope category at treatment end. Median FVC decreased significantly during the study. Treatment was well tolerated. Of 330 PE-A procedures, 0.9% were associated with potentially related adverse events.

conclusionAlthough functional impairment progressed, about two-thirds of patients showed a slower than expected rate of decline at treatment end. Most patients had unaltered (54.5%) or reduced (36.4%) ALSFRS-R slope progression at treatment end. Further evaluation of PE-A in controlled studies involving more patients is warranted. EUDRACT NUMBER: 2013-004842-40.

trial registrationClinicalTrials.gov identifier: NCT02479802.

Indexed as

Amyotrophic Lateral SclerosisAdultAlbuminsDisease ProgressionHumansPilot ProjectsPlasma ExchangeProspective StudiesAlbuminsAlbuminAmyotrophic lateral sclerosisCognitive functionMotor dysfunctionPlasma exchange

Identifiers

PMID34791571
PMCPMC9018657
OpenAlexW3211522394

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.