None listed
Conditions
Brief summary
This is a prospective, rater-blinded, randomised pilot study to compare the outcome of severe GBS patients (Hughes GBS Disability Scale 4 and 5) treated with TPE vs those patients treated with IVIg. We hypothesise that TPE will lead to improved outcomes in comparison to IVIg therapy in patients with severe GBS
Interventions
Therapeutic plasma exchange (TPE): is a semi-automated extracorporeal procedure to exchange the plasma with an inert blood replacement such as Albumin. This helps in the progressive dilution of immunoglobulins which are the presumed target in an autoimmune condition.
IRIS TRIAL - THERAPEUTIC PLASMA EXCHANGE PROTOCOL
Machine:
• Centrifugal apheresis machine
Procedure:
• 5 – 7 procedures in 7 – 10 days, on alternate days
• Initial exchange: 1.2 to 1.5 times Total Plasma Volume (TPV), 90-120 mi
Therapeutic plasma exchange (TPE): is a semi-automated extracorporeal procedure to exchange the plasma with an inert blood replacement such as Albumin. This helps in the progressive dilution of immunoglobulins which are the presumed target in an autoimmune condition. IRIS TRIAL - THERAPEUTIC PLASMA EXCHANGE PROTOCOL Machine: • Centrifugal apheresis machine Procedure: • 5 – 7 procedures in 7 – 10 days, on alternate days • Initial exchange: 1.2 to 1.5 times Total Plasma Volume (TPV), 90-120 minutes per session • Subsequent exchanges: 1.0 TPV • Replacement solution: 4% Albumin only Monitoring: • At initiation: FBC, Coag Screen, U& E’s, Liver Function tests • Daily coagulation screen in the morning before the procedure • Every patient to be put on Vit K 10mg IV, daily prophylactically The decision of whether or not a participant receives 5, 6 or 7 procedures will be the decision of the "treating" neurologist/clinician (i.e.not the "study" neurologist/research team) to ensure that the care of the patient is kept independent from the study objectives.
Sponsors
Waikato Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1) A diagnosis of GBS by Cornblath and Asbury criteria . 2) GBS severity of 4 or 5 by Hughes GBS severity scale OR early treatment outcome (EGOS) score of 5 or greater OR early GBS respiratory insufficiency (EGRIS) score of 5 or greater. 3) Able to start assigned treatment within 2 weeks of weakness onset. 4) At least 18 years of age at the time of enrollment. 5) Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1) Any antecedent illness that would interfere with the ability to perform outcome assessments 2) History of an allergy to IVIg 3) History of an allergic reaction to Albumin 4%. 4) History of IgA deficiency with anti-IgA antibodies 5) Known reaction to blood products 6) Patient with strong objection to the use of blood products
Outcome results
None listed