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

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

Figure 1

Feasibility of SVPE and associated complications for the 20 individual patients with GBS. AMeasured in litres. B, central line-associated blood stream infection; C, urinary catheterisation; CVC, central venous catheter; GBS, Guillain-Barré syndrome; HAI, hospital-acquired infection; M, onset of mechanical ventilation; MRC, Medical Research Council; SVPE: small volume plasma exchange; U, catheter-associated urinary tract infection; V, ventilator-associated pneumonia, , spell of hypotension (systolic blood pressure <90 mm Hg); , CVC insertion site bleeding; , hypersensitivity to fresh frozen plasma, shaded squares: fever due to bacterial infection, dotted squares: fever due to suspected viral infection.

Figure 2

Hospital-acquired infections and use of antibiotics in the 20 patients with GBS receiving SVPE compared with the 24 hospital control patients without GBS treated in the same ICU and HDU with a CVC who did not receive SVPE. SVPE (n=20): 20 patients with GBS aged ≥18 years old who were bedbound (GBS disability score ≥4) received SVPE within 2 weeks of the onset of weakness. Non-SVPE (n=24): 24 patients aged ≥18 years old with a diagnosis other than GBS who required a CVC for >2 to ≤8 calendar days after admission to the same ICU and HDU units in the same period as the patients with GBS received SVPE. *P<0.0001. CLABSI, central line-associated blood stream infection; CAUTI, catheter-associated urinary tract infection; CVC, central venous catheter; GBS, Guillain-Barré syndrome; ICU, intensive care unit; SVPE, small volume plasma exchange; VAP, ventilator-associated pneumonia.

Figure 3

Kaplan-Meier estimate (with 95% confidence limits) of the cumulative incidence of restoration of independent walking ability in patients with Guillain-Barré syndrome treated with small volume plasma exchange (SVPE).