Mini-pool Intravenous Immunoglobulin (MP-IVIG) in Guillain-Barré Syndrome
NCT ID: NCT04550611
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-11-30
2022-12-31
Brief Summary
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2. to determine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the complications of Guillain-Barré syndrome (GBS).
* The MP-IVIG was tolerated and presented no safety issues in a previous study and we will be confirmed by monitoring any adverse events (anaphylaxis and haemolysis) ( no or mild or moderate) and reporting them to ethical committee safety monitoring group.
* Efficacy will be confirmed by:
1. Patient able to walk
2. Improvement of general health.
3. Integration in to social live
3. to compare the efficacy of IVIg to plasma exchange (PE) in hastening recovery and improving the condition of GBS
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Detailed Description
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GBS is a post infectious disorder. The most frequently identified preceding infection is Campylobacter jejuni. Others are cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, and Haemophilus influenzae . Many reports have documented the occurrence of GBS shortly after vaccinations, operations, or stressful events, but the causality and pathophysiology are still debated .
Rapidly progressive weakness is the core clinical feature of GBS. By definition, maximal weakness is reached within 4 weeks, but most patients reach it within 2 to 3 weeks. Thereafter, patients enter a plateau phase that ranges from days to several weeks or months . This phase is followed by a usually much slower and variable recovery phase. In Europe, about one-third of GBS patients remain able to walk ("mild patients") .about 25% of the GBS patients who are unable to walk ("severe patients") need artificial ventilation. This is predominantly due to weakness of the respiratory muscles. GBS has a great impact on social life and the ability to perform activities of daily life. therefore, GBS remains a severe disease for which better treatments are required .
. Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma processing methods. The preparation of the Immunoglobulin G (IgG) plasma fractionation from 20 blood donations which are tested for anti-A and anti-B titre \< 32. Implementable with minimum infrastructural requirements. They developed viral inactivation and protein purification technologies in single-use equipment to prepare virally safe solvent/detergent-filtered (S/D-F) plasma Producing a 90%pure immunoglobulin fraction in disposable single-use devices for transfusion .
IVIG adverse events (AEs) are not frequent; hemolysis after IVIG is a known, rare complication. Higher doses and non-O blood group are key risk factors. The incidence of post-IVIG hemolysis is estimated at 1 per 1000 IVIG treatment episodes, most of which occur within 2 days of exposure. Although the preparation of blood group specific IVIGs in industry is a complex issue because of the pooling of thousands of plasma donations per batch, the preparation of blood group-specific mini-pool IVIG (MP-IVIG) is possible because each pool consists of only 20 plasma donations. Blood group-matched MP-IVIG is assumed to reduce the incidence of IVIG-associated hemolysis, which is largely caused by the presence of anti-A and anti-B agglutinins reacting with non-O blood group recipients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mini-pool Intravenous Immunoglobulin (MP-IVIG)
will receive blood group -specific MP-IVIG in a regimen of 2 g/kg bodyweight, usually as 0.4 g/kg bodyweight per day for five consecutive days within two weak of onset of symptoms.
Mini-pool Intravenous Immunoglobulin (MP-IVIG)
The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
plasmapheresis
plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms.
plasma exchange
plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms.
Interventions
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Mini-pool Intravenous Immunoglobulin (MP-IVIG)
The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
plasma exchange
plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both sex are include
* The study will include patient diagnosed as Guillain-Barré syndrome (mild) cases in neuropsychiatric hospital at Assiut university hospitals.
Exclusion Criteria
* Patient with renal impairment
* Patient with hepatic cell failure
18 Years
40 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Hend Ahmed Hassan Moubark
clinical pathology specialist at assiut university hospitals blood banks
Principal Investigators
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Maha A Mohamed, Prof
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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References
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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.
El-Ekiaby M, Vargas M, Sayed M, Gorgy G, Goubran H, Radosevic M, Burnouf T. Minipool caprylic acid fractionation of plasma using disposable equipment: a practical method to enhance immunoglobulin supply in developing countries. PLoS Negl Trop Dis. 2015 Feb 26;9(2):e0003501. doi: 10.1371/journal.pntd.0003501. eCollection 2015 Feb.
El-Ekiaby M, Sayed MA, Caron C, Burnouf S, El-Sharkawy N, Goubran H, Radosevich M, Goudemand J, Blum D, de Melo L, Soulie V, Adam J, Burnouf T. Solvent-detergent filtered (S/D-F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system. Transfus Med. 2010 Feb;20(1):48-61. doi: 10.1111/j.1365-3148.2009.00963.x. Epub 2009 Sep 23.
Winiecki S, Baer B, Chege W, Jankosky C, Mintz P, Baker M, Woodworth T, Nguyen M. Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin. Transfusion. 2015 Jul;55 Suppl 2:S28-35. doi: 10.1111/trf.13116.
Ojha R, Karn R(2019):Clinical outcome of intravenous immunoglobulin in the treatment of Guillain Barre Syndrome in a Nepalese tertiary centre. Nep Med J 2019;2(1):133-7.
Hughes RA, Cornblath DR. Guillain-Barre syndrome. Lancet. 2005 Nov 5;366(9497):1653-66. doi: 10.1016/S0140-6736(05)67665-9.
Other Identifiers
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Guillain-Barré syndrome
Identifier Type: -
Identifier Source: org_study_id
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