Small Volume Plasma Exchange (SVPE) for Guillain-Barré Syndrome (GBS) Patients

Summary

Guillain-Barré syndrome (GBS) is the commonest form of acute flaccid paralysis and the incidence is high in low-income countries. In Bangladesh, most GBS patients are poor. Therefore patients cannot afford expensive specific treatments like intravenous immunoglobulin (IVIg) or plasmapheresis (PE) in part explaining the high mortality and disability compared to treated patients in high-income countries. Added difficulty in traditional PE is its unavailability and specialized device and manpower dependency. Most research in GBS has been conducted in high-income countries, largely in patients with a demyelinating form of GBS. Axonal form of GBS is common in low-income and Asian countries which has a different pathogenesis, clinical course and outcome than the demyelinating form. Very few therapeutic studies have been conducted in low-income countries due to expensive existing modalities of treatment. Here, the investigators propose SVPE as a treatment for GBS in patients from low-income countries. SVPE is relatively cheap, can be done at the bedside without any special device or electricity and eventually is expected to help poor severely affected GBS patients in underdeveloped and developing countries. The main outcomes will be the safety and feasibility of SVPE since this is yet to be established in the resource limited settings. To be able to evaluate the safety of SVPE, additional information will be acquired about the frequency of complications in non-GBS patients with a central line, treated during the same time period at the same study facility as the GBS patients. Severe sepsis due to central line associated blood stream infection and deep venous thrombosis in the limb where the central venous catheter will be inserted during or following the SVPE procedure, will be defined as severe adverse effect (SAE) and will be considered as primary outcome measure for safety. Blood, cerebrospinal fluid and other relevant biological specimens will be analysed for diagnosis and screening for infections. In addition clinical and neurological outcome assessment will be monitored until discharge of the patient from the hospital and up to four weeks since study entry. Confirmation of feasibility and safety, will eventually lead to a randomized control trial in future with a primary focus on the clinical efficacy of SVPE for the treatment of GBS in developing countries as an alternative for the conventional treatment with IVIg or PE.

Conditions

• Guillain-Barré Syndrome

Interventions

PROCEDURE

Small Volume Plasma Exchange

Six sessions will be done daily for consecutive 8 days (total 48 sessions). 7 ml/body weight blood will be drawn at each session and will be separated into plasma and blood cells. Blood cells will be infused back to the patients and plasma will replaced by equal volume of fresh frozen plasma and colloid solution. At the end of each day 1200 ml plasma (total 9600 ml in 48 sessions) will be removed.

Sponsors & Collaborators

• GBS-CIDP Foundation International

  collaborator UNKNOWN

• National Institute of Neurosciences and Hospital, Dhaka

  collaborator OTHER_GOV

• Erasmus Medical Center

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Principal Investigators

• Zhahirul Islam, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-01

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Bangladesh

Study Locations