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

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ClinicalTrials.gov Identifier: NCT02780570
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : July 27, 2017
Sponsor:
Collaborators:
GBS-CIDP Foundation International
National Institute of Neuroscience, Dhaka, Bangladesh
Erasmus Medical Center
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Guillain-Barré Syndrome Procedure: Small Volume Plasma Exchange Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Small Volume Plasma Exchange (SVPE) for Guillain-Barré Syndrome Patients in Bangladesh: A Safety and Feasibility Study
Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016


Arm Intervention/treatment
Active Comparator: GBS patients
Small Volume Plasma Exchange
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.

No Intervention: non-GBS
non-GBS patients with central venous catheter



Primary Outcome Measures :
  1. Number of participants in whom up to eight liters of plasma could be removed [ Time Frame: 8 days ]
  2. Number of participants who complete forty sessions of SVPE [ Time Frame: 8 days ]
  3. Number of patients developing severe sepsis or septic shock due to CLABSI in SVPE treated GBS patients [ Time Frame: 8 days ]
  4. Number of patients with venous thrombosis in the limb where the central venous catheter [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. Proportion of central venous catheter blockade that requires catheter replacement. [ Time Frame: 8 days ]
  2. Required education time (in days) to acquire expertise to do the SVPE procedure by the responsible staff doctors and nurses [ Time Frame: 8 days ]
  3. Relative risk of CLABSI due to SVPE compared to CLABSI in non-GBS patients treated with a central line at the same ICU [ Time Frame: 8 days ]
  4. Variations of systolic blood pressure greater than 30mm Hg within 30 minutes after starting SVPE [ Time Frame: 30 minutes ]
  5. 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 [ Time Frame: 8 days ]
  6. Development of anaemia (Hb <7 gm./dl) or haemorrhage requiring blood transfusion. [ Time Frame: 8 days ]
  7. Sudden bradycardia involving a reduction of heart rate by more than 20 beats per minute within 30 minutes after starting SVPE [ Time Frame: 30 minutes ]
  8. Rise in heart rate above 120 beats per minute within 30 minutes after starting SVPE [ Time Frame: 30 minutes ]
  9. Improvement by one or more grades in GBS disability score [ Time Frame: 4 weeks ]

    GBS disability score is graded on a scale of 0 - 6

    0: A healthy state

    1. Minor symptoms and capable of running
    2. Able to walk 10 meters or more without assistance but unable to run
    3. Able to walk 10 meters across an open space with help
    4. Bedridden or chair bound
    5. Requiring assisted ventilation for at least part of the day
    6. Dead



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780570


Locations
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Bangladesh
National Institute of Neuroscience
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
GBS-CIDP Foundation International
National Institute of Neuroscience, Dhaka, Bangladesh
Erasmus Medical Center
Investigators
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Principal Investigator: Zhahirul Islam, PhD International Centre for Diarrhoeal Disease Research, Bangladesh

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02780570     History of Changes
Other Study ID Numbers: PR-15086
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
SVPE
intravenous immunoglobulin
plasmapheresis

Additional relevant MeSH terms:
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Syndrome
Guillain-Barre Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases