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IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

Primary Purpose

Guillain-Barre Syndrome

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
plasmapheresis device
Intravenous immunoglobulin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guillain-Barre Syndrome focused on measuring IVIG / plasmapheresis and Guillain-Barre Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18-70 years old,
  • Onset: Recent onset of GBS through the first 2 weeks.
  • Gender: Male or Female Inclusion Criteria.

Exclusion Criteria:

  • patients with metabolic disorders, or malignancy,
  • other causes of peripheral neuropathy

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1 plasmapheresis

Arm 2: Intravenous injection of immunoglobulin

Arm Description

Arm 1 (plasmapheresis): This study will be conducted at Assiut University at Neurology and psychiatry department as Group 1 of patients presented with Guillian Barrie syndrome (54 patients) will be subjected to plasmapheresis after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up)

This study will be conducted at Assiut University at Neurology and psychiatry department as Group 2 of patients presented with Guillian Barrie syndrome (27 patients) will be subjected to intravenous injection of immunoglobulin after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score, and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up).

Outcomes

Primary Outcome Measures

Clinical grading scale MRC ( medial research council sum score )
Clinical grading scale MRC ( medial research council sum score ) from zero ( no power ) up to 60 full power (points): sum score of muscle power in both upper limbs and lower limbs in points .
Overall neuropathy limitations scale (ONLS) .
it is modified disability sum score: sum of arm grade and leg grade limitation score; arm grade from zero point ( less limitation ) to 5 points ( most limitation ) and leg grade from zero point ( less limitation) to 7 points (more limitation)
ERASMUS GBS respiratory insufficiency score EGRIS
Predict the probability of respiratory insufficiency within the first week of admission, in individual patients with Guillain-Barre. syndrome from zero to 7 points score : 0 point ( no affection ) , 7 point ( severe affection )

Secondary Outcome Measures

Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second
Neurophysiological study neurophysiological study pre- and after 3 months change of degree of affection and improvement in latency in nerve conduction m/ sec. amplitude m/v , velocity of nerve /s conduction and F-wave of both upper limbs and lower limbs

Full Information

First Posted
October 21, 2021
Last Updated
April 4, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05104762
Brief Title
IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients
Official Title
IVIG Versus Plasmapheresis and Guillian Barrie Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the investigators address the question: whether treatment with IVIG is superior to treatment using plasmapheresis for functional recovery of patients with GBS? Recovery was quantified using: The changes in the A-Clinical grading scale MRC ( medial research council sum score ) and B-overall neuropathy limitations scale as the primary outcome and the changes in Neurophysiological study 3 months after treatment as a secondary outcome. This information will be used to evaluate which treatment is more beneficial to GBS patients.
Detailed Description
Guillain-Barré syndrome (GBS) is an inflammatory disease of the PNS and is the most common cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per 100,000 person-years. Patients with GBS typically present with weakness and sensory signs in the legs that progress to the arms and cranial muscles, although the clinical presentation of the disease is heterogeneous and several distinct clinical variants exist. Diagnosis of GBS is based on the patient's history and neurological, electrophysiological, and cerebrospinal fluid (CSF) examinations. Electrophysiological studies: provide evidence of peripheral nervous system (PNS) dysfunction and can distinguish between the subtypes of GBS: acute inflammatory demyelinating polyradiculoneuropathy (AIDP), acute motor axonal neuropathy (AMAN), and acute motor-sensory axonal neuropathy (AMSAN). Disease progression can be rapid, and most patients with GBS reach their maximum disability within 2 weeks. About 20% of patients with GBS develop respiratory failure and require mechanical ventilation. Cardiac arrhythmias and blood pressure instability can occur owing to the involvement of the autonomic nervous system. Immunomodulatory therapy should be started if patients are unable to walk independently for 10 m. Evidence on treatment efficacy in patients who can still walk independently is limited, but treatment should be considered, especially if these patients display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction, bulbar failure, or respiratory insufficiency. Clinical trials have demonstrated a treatment effect for intravenous immunoglobulin (IVIg) when started within 2 weeks of the onset of weakness and for plasma exchange when started within 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barre Syndrome
Keywords
IVIG / plasmapheresis and Guillain-Barre Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2 groups of patients with Guillian Barrie syndrome were subjected to plasmapheresis or IVIG by percentage 2:1 respectively according to availability of IVIG
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple-blind (participant and investigator, accessor) using closed envelope 2:1 was applied. 5 sessions of plasmapheresis: IVIG 0.4g IVIG/Kg /day for 5 consecutive days. The investigators didn't know what was the type of treatment that patients received and the patient didn't know that there is another line of treatment.
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 plasmapheresis
Arm Type
Active Comparator
Arm Description
Arm 1 (plasmapheresis): This study will be conducted at Assiut University at Neurology and psychiatry department as Group 1 of patients presented with Guillian Barrie syndrome (54 patients) will be subjected to plasmapheresis after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up)
Arm Title
Arm 2: Intravenous injection of immunoglobulin
Arm Type
Active Comparator
Arm Description
This study will be conducted at Assiut University at Neurology and psychiatry department as Group 2 of patients presented with Guillian Barrie syndrome (27 patients) will be subjected to intravenous injection of immunoglobulin after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score, and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up).
Intervention Type
Device
Intervention Name(s)
plasmapheresis device
Other Intervention Name(s)
plasma exchange device
Intervention Description
Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions)
Intervention Type
Drug
Intervention Name(s)
Intravenous immunoglobulin
Other Intervention Name(s)
IVIG
Intervention Description
group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.
Primary Outcome Measure Information:
Title
Clinical grading scale MRC ( medial research council sum score )
Description
Clinical grading scale MRC ( medial research council sum score ) from zero ( no power ) up to 60 full power (points): sum score of muscle power in both upper limbs and lower limbs in points .
Time Frame
the points change from baseline scale and after 3 months follow up
Title
Overall neuropathy limitations scale (ONLS) .
Description
it is modified disability sum score: sum of arm grade and leg grade limitation score; arm grade from zero point ( less limitation ) to 5 points ( most limitation ) and leg grade from zero point ( less limitation) to 7 points (more limitation)
Time Frame
the changes in points from baseline assessment score to 3 months follow up assessment score.
Title
ERASMUS GBS respiratory insufficiency score EGRIS
Description
Predict the probability of respiratory insufficiency within the first week of admission, in individual patients with Guillain-Barre. syndrome from zero to 7 points score : 0 point ( no affection ) , 7 point ( severe affection )
Time Frame
the change in points from baseline assessment score to 3 months follow up assessment score.
Secondary Outcome Measure Information:
Title
Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second
Description
Neurophysiological study neurophysiological study pre- and after 3 months change of degree of affection and improvement in latency in nerve conduction m/ sec. amplitude m/v , velocity of nerve /s conduction and F-wave of both upper limbs and lower limbs
Time Frame
the change in points from baseline assessment score to 3 months follow up assessment score.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-70 years old, Onset: Recent onset of GBS through the first 2 weeks. Gender: Male or Female Inclusion Criteria. Exclusion Criteria: patients with metabolic disorders, or malignancy, other causes of peripheral neuropathy
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
15668421
Citation
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Results Reference
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Citation
van Koningsveld R, Steyerberg EW, Hughes RA, Swan AV, van Doorn PA, Jacobs BC. A clinical prognostic scoring system for Guillain-Barre syndrome. Lancet Neurol. 2007 Jul;6(7):589-94. doi: 10.1016/S1474-4422(07)70130-8.
Results Reference
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PubMed Identifier
24163275
Citation
Fokke C, van den Berg B, Drenthen J, Walgaard C, van Doorn PA, Jacobs BC. Diagnosis of Guillain-Barre syndrome and validation of Brighton criteria. Brain. 2014 Jan;137(Pt 1):33-43. doi: 10.1093/brain/awt285. Epub 2013 Oct 26.
Results Reference
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PubMed Identifier
21403108
Citation
Walgaard C, Lingsma HF, Ruts L, van Doorn PA, Steyerberg EW, Jacobs BC. Early recognition of poor prognosis in Guillain-Barre syndrome. Neurology. 2011 Mar 15;76(11):968-75. doi: 10.1212/WNL.0b013e3182104407.
Results Reference
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PubMed Identifier
22786475
Citation
Raphael JC, Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD001798. doi: 10.1002/14651858.CD001798.pub2.
Results Reference
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PubMed Identifier
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Citation
van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.
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PubMed Identifier
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Citation
van Doorn PA. Diagnosis, treatment and prognosis of Guillain-Barre syndrome (GBS). Presse Med. 2013 Jun;42(6 Pt 2):e193-201. doi: 10.1016/j.lpm.2013.02.328. Epub 2013 Apr 28.
Results Reference
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PubMed Identifier
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Citation
van Nes SI, Vanhoutte EK, van Doorn PA, Hermans M, Bakkers M, Kuitwaard K, Faber CG, Merkies IS. Rasch-built Overall Disability Scale (R-ODS) for immune-mediated peripheral neuropathies. Neurology. 2011 Jan 25;76(4):337-45. doi: 10.1212/WNL.0b013e318208824b.
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IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

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