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, 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
Abstract
Objective: To assess the safety and feasibility of small volume plasma exchange (SVPE) for patients with Guillain-Barré syndrome (GBS).
Design: Non-randomised, single-arm, interventional trial.
Setting: National Institute of Neurosciences and Hospital, Dhaka, Bangladesh.
Participants: Twenty 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.
Interventions: SVPE 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.
Results: Median 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.
Conclusion: SVPE 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.
Keywords: Guillain-Barré syndrome; feasibility; safety; small volume plasma exchange.
Conflict of interest statement
Competing interests: None declared.
© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Figures
References
- Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barré syndrome. Lancet 2016;388:717–27. 10.1016/S0140-6736(16)00339-1
- Van Koningsveld R, Van Doorn PA, Schmitz PI, et al. . Mild forms of Guillain-Barré syndrome in an epidemiologic survey in The Netherlands. Neurology 2000;54:620–5. 10.1212/WNL.54.3.620
- Asbury AK, Arnason BG, Adams RD. The inflammatory lesion in idiopathic polyneuritis. Its role in pathogenesis. Medicine 1969;48:173–215.
- Anon. Efficiency of plasma exchange in Guillain-Barré syndrome: role of replacement fluids. French Cooperative Group on Plasma Exchange in Guillain-Barré syndrome. Ann Neurol 1987;22:753–61. 10.1002/ana.410220612
- Anon. Appropriate number of plasma exchanges in Guillain-Barré syndrome. The French cooperative group on plasma exchange in Guillain-Barré Syndrome. Ann Neurol 1997;41:298–306. 10.1002/ana.410410304
- Anon. Plasma exchange in Guillain-Barré syndrome: one-year follow-up. French Cooperative Group on Plasma Exchange in Guillain-Barré Syndrome. Ann Neurol 1992;32:94–7. 10.1002/ana.410320115
- Anon. Plasmapheresis and acute Guillain-Barré syndrome. The Guillain-Barré syndrome Study Group. Neurology 1985;35:1096–104.
- Greenwood RJ, Newsom-Davis J, Hughes RA, et al. . Controlled trial of plasma exchange in acute inflammatory polyradiculoneuropathy. Lancet 1984;1:877–9. 10.1016/S0140-6736(84)91341-2
- Osterman PO, Fagius J, Lundemo G, et al. . Beneficial effects of plasma exchange in acute inflammatory polyradiculoneuropathy. Lancet 1984;2:1296–9. 10.1016/S0140-6736(84)90819-5
- Hughes RAC, Swan AV, van Doorn PA. Cochrane Neuromuscular Group. Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Database Syst Rev 2014;46.
- Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barré syndrome. Cochrane Database Syst Rev 2017;2:CD001798 10.1002/14651858.CD001798.pub3
- Hughes RA, Wijdicks EF, Barohn R, et al. . Practice parameter: immunotherapy for Guillain-Barré syndrome: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2003;61:736–40. 10.1212/WNL.61.6.736
- van der Meché FG, Schmitz PI. A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barré syndrome. Dutch Guillain-Barré Study Group. N Engl J Med 1992;326:1123–9. 10.1056/NEJM199204233261705
- Islam MB, Islam Z, Farzana KS, et al. . Guillain-Barré syndrome in Bangladesh: validation of Brighton criteria. J Peripher Nerv Syst 2016;21:345–51. 10.1111/jns.12189
- Islam Z, Jacobs BC, van Belkum A, et al. . Axonal variant of Guillain-Barre syndrome associated with Campylobacter infection in Bangladesh. Neurology 2010;74:581–7. 10.1212/WNL.0b013e3181cff735
- Ishaque T, Islam MB, Ara G, et al. . High mortality from Guillain-Barré syndrome in Bangladesh. J Peripher Nerv Syst 2017;22:121–6. 10.1111/jns.12215
- Islam MB, Islam Z, Rahman S, et al. . Small volume plasma exchange for Guillain-Barré syndrome in resource poor settings: a safety and feasibility study. Pilot Feasibility Stud 2017;3:40 10.1186/s40814-017-0185-0
- Asbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barré syndrome. Ann Neurol 1990;27 (suppl):S21–24.
- Centers for Disease Control and Prevention. Bloodstream infection event (central line-associated bloodstream infection and non-central line associated bloodstream infection. 2018. (accessed 8 Jun 2018).
- Hughes RA, Newsom-Davis JM, Perkin GD, et al. . Controlled trial prednisolone in acute polyneuropathy. Lancet 1978;2:750–3. 10.1016/S0140-6736(78)92644-2
- Kleyweg RP, van der Meché FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome. Muscle Nerve 1991;14:1103–9. 10.1002/mus.880141111
- Graham RC, Hughes RA. A modified peripheral neuropathy scale: the overall neuropathy limitations scale. J Neurol Neurosurg Psychiatry 2006;77:973–6. 10.1136/jnnp.2005.081547
- van Nes SI, Vanhoutte EK, van Doorn PA, et al. . Rasch-built Overall Disability Scale (R-ODS) for immune-mediated peripheral neuropathies. Neurology 2011;76:337–45. 10.1212/WNL.0b013e318208824b
- Pronovost PJ, Goeschel CA, Colantuoni E, et al. . Sustaining reductions in catheter related bloodstream infections in Michigan intensive care units: observational study. BMJ 2010;340:c309 10.1136/bmj.c309
- Flodgren G, Conterno LO, Mayhew A, et al. . Interventions to improve professional adherence to guidelines for prevention of device-related infections. Cochrane Database Syst Rev 2013;3:Cd006559 10.1002/14651858.CD006559.pub2
- O’Grady NP, Alexander M, Burns LA, et al. . Summary of recommendations: guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis 2011;52:1087–99. 10.1093/cid/cir138
- Centers for Disease Control & Prevention. Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and Non-Catheter-Associated Urinary Tract Infection [UTI]) and Other Urinary System Infection [USI]) Events. 2018.
- Centers for Disease Control & Prevention. Pneumonia (Ventilator-associated [VAP] and non-ventilator-associated Pneumonia [PNEU]) Event. 2018.
- Centers for Disease Control & Prevention. Identifying Healthcare-associated Infections (HAI) for NHSN Surveillance. 2018.
- Centers for Disease Control & Prevention. CDC/NHSN Surveillance definitions for specific types of infections. 2018.
- The Dutch Guillain-Barre Study Group. Treatment of Guillain-Barre syndrome with high-dose immune globulins combined with methylprednisolone: a pilot study. Ann Neurol 1994;35:749–52.
- Garssen MP, van Koningsveld R, van Doorn PA, et al. . Treatment of Guillain-Barré syndrome with mycophenolate mofetil: a pilot study. J Neurol Neurosurg Psychiatry 2007;78:1012–3. 10.1136/jnnp.2006.102731
- Stigler SM. The true title of Bayes’s essay. Statistical Science 2013;28:283–8. 10.1214/13-STS438
- Freedman LS, Spiegelhalter DJ, Parmar MK. The what, why and how of Bayesian clinical trials monitoring. Stat Med 1994;13:1371–83. 10.1002/sim.4780131312
- Resnic FS, Zou KH, Do DV, et al. . Exploration of a bayesian updating methodology to monitor the safety of interventional cardiovascular procedures. Med Decis Making 2004;24:399–407. 10.1177/0272989X04267012
- Gonzalez-Quintela A, Alende R, Gude F, et al. . Serum levels of immunoglobulins (IgG, IgA, IgM) in a general adult population and their relationship with alcohol consumption, smoking and common metabolic abnormalities. Clin Exp Immunol 2008;151:42–50. 10.1111/j.1365-2249.2007.03545.x
- McKhann GM, Griffin JW, Cornblath DR, et al. . Plasmapheresis and Guillain-Barré syndrome: analysis of prognostic factors and the effect of plasmapheresis. Ann Neurol 1988;23:347–53. 10.1002/ana.410230406
- Tharakan J, Jayaprakash PA, Iyer VP. Small volume plasma exchange in Guillain-Barre syndrome: experience in 25 patients. J Assoc Physicians India 1990;38:550–3.
- Iyer RR, Shah PH, Roy SS, et al. . Reducing the economic burden in management of Guillain-Barre syndrome using modified plasmapheresis. Asian J Transfus Sci 2016;10:118–21. 10.4103/0973-6247.187940
- Izak M, Bussel JB. Management of thrombocytopenia. F1000Prime Rep 2014;6 10.12703/P6-45
Source: PubMed