@article{f2045c444b2e4667b0a4d48ff47d6a4b,
title = "Second IVIg course in Guillain-Barr{\'e} syndrome patients with poor prognosis (SID-GBS trial): Protocol for a double-blind randomized, placebo-controlled clinical trial",
abstract = "One course of intravenous immunoglobulins (IVIg) of 2 g/kg is standard treatment in Guillain-Barr{\'e} syndrome (GBS) patients unable to walk independently. Despite treatment some patients recover poorly, in part related to rapid consumption of IVIg, indicating that they may benefit from a second course of IVIg. The aim of the study is to determine whether a second course of IVIg, administered 1 week after start of the first course in patients with GBS and predicted poor outcome improves functional outcome on the GBS disability scale after 4 weeks. Secondary outcome measures include adverse events (AEs), Medical Research Council sumscore and GBS disability score after 8, 12, and 26 weeks, length of hospital and ICU admission, mortality, and changes in serum IgG levels. GBS patients of 12 years and older with a poor prognosis, based on the modified Erasmus GBS outcome score (mEGOS) at 1 week after start of the first IVIg course are eligible for randomization in this double-blind, placebo-controlled (IVIg or albumin) clinical trial. This study will determine if a second course of IVIg administered in the acute phase of the disease is safe, feasible, and effective in patients with GBS and a poor prognosis. This Dutch trial is registered prospectively as NTR 2224 in the Netherlands National Trial Register (NTR) which is the Primary Registry in the WHO Registry Network for the Netherlands.",
keywords = "Guillain-Barr{\'e} syndrome, IVIg, protocol, treatment, trial",
author = "{the Dutch GBS Study Group} and Christa Walgaard and Jacobs, {Bart C.} and Lingsma, {Hester F.} and Steyerberg, {Ewout W.} and Cornblath, {David R.} and {van Doorn}, {Pieter A.} and {de Wit}, {M. C.Y.} and {van den Berg}, B. and Doets, {A. Y.} and Leonhard, {S. E.} and Verboon, {J. C.} and {van Woerkom}, M. and Tio-Gillen, {A. P.} and {van Rijs}, W. and H. Huizinga and Badrising, {U. A.} and Bienfait, {H. M.E.} and Blom, {R. J.} and {van Boheemen}, {C. J.M.} and Breukelman, {A. J.} and Bronner, {I. M.} and Dieks, {H. J.G.} and {van Dijk}, {G. W.} and {van Engelen}, {B. G.M.} and Faber, {C. G.} and B. Feenstra and C. Fokke and Garssen, {M. P.J.} and Gijsbers, {C. J.} and Gilhuis, {H. J.} and {van der Graaff}, {M. M.} and Groen, {R. J.} and Hoogendoorn, {T. A.} and A. Hovestad and Jansen, {P. J.H.W.} and K. Jellema and E. Keuter and Kleyweg, {R. P.} and {van Koningsveld}, R. and {van der Kooi}, {A. J.} and {van der Kooi}, {E. L.} and J. Krudde and Kuks, {J. B.M.} and K. Kuitwaard and Linssen, {W. H.J.P.} and J. Lion and H. Lovenich and Manschot, {S. M.} and Mellema, {S. J.} and Merkies, {I. S.J.}",
note = "Funding Information: information Prinses Beatrix Spierfonds, Grant/Award Number: WAR07-28; Sanquin plasma productsThe SID-GBS trial is an investigator initiated, independent academic trial. The study is run by a large group of local principal investigators (Dutch GBS Study Group), and a steering committee from the Erasmus medical center, both are involved in the inclusion, randomization, and follow-up of the patients. Together they form the SID-GBS Study Group (Appendix). Decisions regarding continuation, amendments to the protocol, and publication of the results will be taken by the steering committee. The results of this study will be published in the name of the SID-GBS Study Group. The study is funded by the Prinses Beatrix Spierfonds (WAR07-28) and Sanquin plasma products. Funding Information: The SID-GBS trial is an investigator initiated, independent academic trial. The study is run by a large group of local principal investigators (Dutch GBS Study Group), and a steering committee from the Erasmus medical center, both are involved in the inclusion, randomization, and follow-up of the patients. Together they form the SID-GBS Study Group (Appendix). Decisions regarding continuation, amendments to the protocol, and publication of the results will be taken by the steering committee. The results of this study will be published in the name of the SID-GBS Study Group. The study is funded by the Prinses Bea-trix Spierfonds (WAR07-28) and Sanquin plasma products. Publisher Copyright: {\textcopyright} 2018 Peripheral Nerve Society",
year = "2018",
month = dec,
day = "1",
doi = "10.1111/jns.12286",
language = "English (US)",
volume = "23",
pages = "210--215",
journal = "Journal of the Peripheral Nervous System",
issn = "1085-9489",
publisher = "Wiley-Blackwell",
number = "4",
}