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

Abstract

Background: In Bangladesh, most patients with Guillain-Barré syndrome (GBS) cannot afford standard treatment with intravenous immunoglobulin (IVIG) or a standard plasma exchange (PE) course, which partly explains the high rate of mortality and residual disability associated with GBS in this country. Small volume plasma exchange (SVPE) is an affordable and potentially effective alternative form of plasma exchange. SVPE is the repeated removal of small volumes of supernatant plasma over several days via sedimentation of patient whole blood. The aim of this study is to define the clinical feasibility and safety of SVPE in patients with GBS in resource poor settings.

Methods: A total of 20 adult patients with GBS will be enrolled for SVPE at a single center in Bangladesh. Six daily sessions of whole blood sedimentation and plasma removal will be performed in all patients with GBS with a target to remove an overall volume of at least 8 liters (L) of plasma over a total of 8 days. Serious adverse events (SAE) are defined as the number of patients developing severe sepsis associated with the central venous catheter or deep venous thrombosis in the limb where the catheter is placed for SVPE. Based upon a predictive success rate of 75%, the SVPE procedure will be considered safe if less than 5 of 20 SVPE-treated GBS patients have a SAE. The procedure will be considered feasible if 8 L of plasma can be removed in at least 15 of 20 patients with GBS who receive SVPE. In addition, detailed clinical and neurological outcome assessments will be performed until discharge of the patient from the hospital and up to 4 weeks after study entry.

Discussion: This is the first clinical study to evaluate the feasibility and safety of SVPE as a potential alternative low-cost treatment for the patients with GBS in resource poor settings.

Trial registration: Clinicaltrials.gov NCT02780570.

Keywords: Feasibility; Guillain-Barré syndrome; HDU; ICU; IVIG; PE; SAE; SVPE; Safety.

Conflict of interest statement

Ethics approval and consent to participate

The Institutional Review Board (IRB) of the icddr,b, comprised of an Ethical Review Committee (ERC) and Research Review Committee (RRC) reviewed and approved this study protocol on 09/12/2015 (reference number: PR-15086, version no 3). In this manuscript, we did not report any human data.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Consolidated Standards of Reporting Trials (CONSORT) diagram for the small volume plasma exchange (SVPE) safety and feasibility study

Fig. 2

Illustration of the small volume plasma exchange (SVPE) kit. A SVPE kit will be prepared with one blood transfusion set and two saline infusion sets connected via a tri-channel device. The blood transfusion set will be connected to the blood bag and a saline infusion set will be connected to 1 L normal saline mixed with 2500 units of unfractionated heparin and the other ends of the blood transfusion and saline infusion sets will be connected with one lumen of the central venous catheter using a tri-channel device. Another saline infusion set will be connected to 500 mL hexa-ethyl starch solution and the other end connected with the second lumen of the central venous catheter. Air should be eliminated from all tubes using fluid from the respective bags

Fig. 3

SVPE procedure for patients with GBS. A loading dose of low-molecular weight heparin (1.5 mg/kg) will be given subcutaneously at least 2 hours before initiation of SVPE; the same dose will be administered once daily or divided into two equal doses daily for 8 days or until SVPE is completed. Whole blood (7 mL/kg body weight) will be drawn from the central venous catheter into the blood transfusion bag in each session. The blood bag will be hung beside the patient for 2.5 h on a saline stand and left uninterrupted to allow plasma and blood cells to separate. The blood cells will be infused back into the patient and plasma will be discarded and replaced with fresh frozen plasma and colloid solution alternately (in equal volumes) via the closed-circuit SVPE kit illustrated in Fig. 2. In case of excessive clotting (bleeding time reduction of > 50% of baseline for that patient), aspirin (600 mg) will be administered orally at least 2 hours before the next SVPE session and continued thereafter at 150 mg orally/day until SVPE is completed. One blood bag will be used each day, with a total of six sessions/day. A total of 48 sessions will be performed over 8 days, removing approximately 8000 mL plasma in total