DOI: 10.5061/dryad.55nb389
title: Data from: Small volume plasma exchange for Guillain-Barré syndrome in resource-limited settings: a phase II safety and feasibility study

description: OBJECTIVE: To assess the safety and feasibility of small volume plasma
 exchange (SVPE) as an alternative to standard plasma exchange (PE) or
 intravenous immunoglobulin (IVIg) for Guillain-Barré syndrome (GBS)
 patients. DESIGN: Non-randomized, single arm, interventional trial.
 SETTING: National Institute of Neurosciences and Hospital, Dhaka,
 Bangladesh. PARTICIPANTS: Twenty adult (&gt;18 years) patients with
 GBS presented within 2 weeks of onset of weakness who were unable to walk
 unaided for more than 10 meters. INTERVENTIONS: SVPE involves blood cell
 sedimentation in a blood bag and removal of supernatant plasma after blood
 cells are re-transfused. This procedure was repeated three to six times a
 day, for eight consecutive days. OUTCOME MEASURES: Serious adverse events
 (SAE) were defined as severe sepsis and deep venous thrombosis related to
 the central vein catheter (CVC) used during SVPE. SVPE was considered safe
 if less than 5/20 patients experienced a SAE, and feasible if 8 L plasma
 could be removed within 8 days in at least 15/20 patients. RESULTS Median
 patient age 33 years (IQR 23-46; range 18-55); 13 (65%) were male. Median
 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). Minor adverse effects were transient hypotension in 10
 (50%) patients; CVC-associated bleeding in 10 (50%); transfusion reaction
 to fresh frozen plasma in 4 (20%); and hypo-albuminemia, anaemia or
 electrolyte imbalance in 4 (20%). Removal of 8 L plasma was possible in 15
 (75%) patients. GBS disability score improved by at least one grade in 14
 (70%) patients four weeks after SVPE started. No patients died.
 CONCLUSION: SVPE seems a safe and feasible alternative treatment to
 standard PE or IVIg for GBS; further studies of clinical efficacy in
 low-resource developing countries are warranted. TRIAL REGISTRATION:
 Clinicaltrials.gov NCT02780570 on May 23, 2016. Strength and limitations
 of the study: 1. The strength of this study underlies the novel and simple
 technique of SVPE, which is much less expensive than conventional
 immunotherapies (plasma exchange and intravenous immunoglobulin). 2. SVPE
 is corroborated as safe and feasible for the first time in a prospective
 and standardized cohort of patients with Guillain-Barré syndrome (GBS). 3.
 The intrinsic limitations of this study are its non-randomized, single arm
 nature, which is conducted in a single center with a limited sample size
 of GBS patients. 4. Clinical efficacy of SVPE on patients with GBS was a
 secondary end-point assessment and therefore deserves a randomized
 controlled trial in future to assess the clinical efficacy of SVPE for the
 patients with GBS.
description: SVPE database.sav for
 data repositoryThis datafile contains
 information regarding the clinical presentation and outcome, hemodynamic,
 biochemical and infection documentation variables for Guillain-Barré
 syndrome patients treated with Small Volume Plasma Exchange
 (SVPE)SVPE
 datafile for data repository.xlsNon SVPE
 datafileThis datafile contains
 information regarding the clinical diagnosis, hemodynamic, biochemical and
 infection documentation parameters for patients without Guillain-Barré
 syndrome who needed a central venous catheter (CVC) for medication. These
 patients were used as control to the Guillain-Barré syndrome patients
 treated with small volume plasma exchange and treated in the same study
 area (ICU/HDU) during the study period