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

NCT02780570 | Completed Phase 2 DMC

• 1 other identifier: PR-15086
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SVPE; intravenous immunoglobulin; plasmapheresis

Outcome Measures

Primary Outcomes (4)

• Number of participants in whom up to eight liters of plasma could be removed

  8 days

• Number of participants who complete forty sessions of SVPE

  8 days

• Number of patients developing severe sepsis or septic shock due to CLABSI in SVPE treated GBS patients

  8 days

• Number of patients with venous thrombosis in the limb where the central venous catheter

  8 days

Secondary Outcomes (9)

• Proportion of central venous catheter blockade that requires catheter replacement.

  8 days

• Required education time (in days) to acquire expertise to do the SVPE procedure by the responsible staff doctors and nurses

  8 days

• Relative risk of CLABSI due to SVPE compared to CLABSI in non-GBS patients treated with a central line at the same ICU

  8 days

• Variations of systolic blood pressure greater than 30mm Hg within 30 minutes after starting SVPE

  30 minutes

• Proportion of participants in whom SVPE had to be discontinued due to poor hemodynamic tolerance or other side effects and the exact time of discontinuation of the SVPE procedure

  8 days

Study Arms (2)

GBS patients

ACTIVE COMPARATOR

Small Volume Plasma Exchange

Procedure: Small Volume Plasma Exchange

non-GBS

NO INTERVENTION

non-GBS patients with central venous catheter

Interventions

Small Volume Plasma Exchange PROCEDURE

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.

GBS patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfill the diagnostic criteria for GBS patients of the National Institute of Neurological and Communicative Disorders and Stroke (NINDS) \[19\]
• ≥ 18 years of age at diagnosis
• unable to walk unaided for more than 10 meters (GBS disability score ≥ 3)
• included within 2 weeks of onset of weakness
• unable to afford standard treatment with IVIg or standard PE
• Informed written consent

You may not qualify if:

• previous severe allergic reaction to properly matched blood products
• evidence of healthcare associated infection present on admission (except aspiration pneumonia)
• severe concomitant illness or terminal underlying disease
• pregnancy

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• GBS-CIDP Foundation International: collaborator
• National Institute of Neurosciences and Hospital, Dhaka: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

National Institute of Neuroscience

Dhaka, 1000, Bangladesh

Location

Related Publications (3)

• Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

  PMID: 23361625 BACKGROUND

• Islam B, Islam Z, Rahman S, Endtz HP, Vos MC, van der Jagt M, van Doorn PA, Jacobs BC, Mohammad QD. Small volume plasma exchange for Guillain-Barre syndrome in resource-limited settings: a phase II safety and feasibility study. BMJ Open. 2018 Aug 17;8(8):e022862. doi: 10.1136/bmjopen-2018-022862.

  PMID: 30121613 DERIVED

• Islam MB, Islam Z, Rahman S, Endtz HP, Vos MC, van der Jagt M, van Doorn PA, Jacobs BC, Mohammad QD. Small volume plasma exchange for Guillain-Barre syndrome in resource poor settings: a safety and feasibility study. Pilot Feasibility Stud. 2017 Sep 29;3:40. doi: 10.1186/s40814-017-0185-0. eCollection 2017.

  PMID: 28975040 DERIVED

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhahirul Islam, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: May 23, 2016
• Study Start: January 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)