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

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.