3 years ago

Small volume plasma exchange for Guillain-Barre 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.

Publisher URL: http://bmjopen.bmj.com/cgi/content/short/8/8/e022862

DOI: 10.1136/bmjopen-2018-022862

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