Evidence map›Paper›PMID 30121613›Full record

Trial reportBMJ open2018

Small volume plasma exchange for Guillain-Barré syndrome in resource-limited settings: a phase II safety and feasibility study.

Badrul Islam, Zhahirul Islam, Shafiqur Rahman, Hubert P Endtz, Margreet C Vos, Mathieu van der Jagt, Peter A van Doorn, Bart C Jacobs, Quazi Deen Mohammad

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02780570 (Small Volume Plasma Exchange), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

NCT02780570 phase2completednot on this map

Small Volume Plasma Exchange (SVPE) for Guillain-Barré Syndrome Patients in Bangladesh: A Safety and Feasibility Study

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2016 to 2016Enrolled20ConditionsGuillain-Barré SyndromeArmsSmall Volume Plasma Exchange
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Guillain-Barré syndrome.Nature reviews. Disease primers · 2024
    Article
  5. Review
  6. Review
  7. Principles of Therapeutic Apheresis in Neurological Disease.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Review
  8. Validation and adjustment of modified Erasmus GBS outcome score in Bangladesh.Annals of clinical and translational neurology · 2022
    Article
  9. Immunoglobulin and Monoclonal Antibody Therapies in Guillain-Barré Syndrome.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. 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

9 authors.

Badrul IslamDepartment of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.
Zhahirul IslamLaboratory Sciences and Services Division (LSSD), The International Centre for Diarrhoeal Disease Research (icddr,b), Dhaka, Bangladesh.
Shafiqur RahmanDepartment of Intensive Care Medicine, Uttara Adhunik Medical College & Hospital, Dhaka, Bangladesh.
Hubert P EndtzDepartment of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.
Margreet C VosDepartment of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.
Mathieu van der JagtDepartment of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.
Peter A van DoornDepartment of Neurology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Bart C JacobsDepartments of Neurology and Immunology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Quazi Deen MohammadDepartment of Neurology, National Institute of Neurosciences (NINS) and Hospital, Dhaka, Bangladesh, National Institute of Neuroscience (NINS), Dhaka, Bangladesh.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the safety and feasibility of small volume plasma exchange (SVPE) for patients with Guillain-Barré syndrome (GBS).

designNon-randomised, single-arm, interventional trial.

settingNational Institute of Neurosciences and Hospital, Dhaka, Bangladesh.

participantsTwenty adult (>18 years) patients with GBS presented within 2 weeks of onset of weakness who were unable to walk unaided for more than 10 m.

interventionsSVPE involves blood cell sedimentation in a blood bag and removal of supernatant plasma after blood cells are retransfused. This procedure was repeated three to six times a day, for eight consecutive days. Fresh frozen plasma (FFP) and normal saline were used as replacement fluid. OUTCOME MEASURES: Serious adverse events (SAEs) were defined as severe sepsis and deep venous thrombosis related to the central venous catheter (CVC) used during SVPE. SVPE was considered safe if less than 5/20 patients experienced an SAE, and feasible if 8 L plasma could be removed within 8 days in at least 15/20 patients.

resultsMedian patient age 33 years (IQR 23-46; range 18-55); 13 (65%) were male. Median Medical Research Council (MRC) sum score was 20 (IQR 0-29; range 0-36); three (15%) patients required mechanical ventilation. One patient developed SAE (severe sepsis, possibly related to CVC). The median plasma volume exchanged was 140 mL/kg (range 110-175) and removal of 8 L plasma was possible in 15 (75%) patients. Patients received a median 1 g/kg IgG via FFP although a substantial proportion of IgG was probably removed again by the SVPE sessions. GBS disability score improved by at least one grade in 14 (70%) patients 4 weeks after SVPE started. No patients died.

conclusionSVPE seems a safe and feasible alternative treatment to standard plasma exchange (PE) or intravenous immunoglobulin (IVIg) for GBS; further studies of clinical efficacy in low-income and middle-income countries are warranted. TRIAL REGISTRATION NUMBER: NCT02780570.

Indexed as

AdolescentAdultFeasibility StudiesFemaleGuillain-Barre SyndromeHumansMaleMiddle AgedPlasma ExchangeTreatment OutcomeYoung AdultfeasibilityGuillain-Barré syndromesafetysmall volume plasma exchange

Identifiers

PMID30121613
PMCPMC6104782

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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.