Islam Md Badrul, Islam Zhahirul, Rahman Shafiqur, Endtz Hubert P, Vos Margreet C, van der Jagt Mathieu, van Doorn Pieter A, Jacobs Bart C, Mohammad Quazi D
Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.
Laboratory Sciences and Services Division (LSSD), International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Pilot Feasibility Stud. 2017 Sep 29;3:40. doi: 10.1186/s40814-017-0185-0. eCollection 2017.
In Bangladesh, most patients with Guillain-Barré syndrome (GBS) cannot afford standard treatment with intravenous immunoglobulin (IVIG) or a standard plasma exchange (PE) course, which partly explains the high rate of mortality and residual disability associated with GBS in this country. Small volume plasma exchange (SVPE) is an affordable and potentially effective alternative form of plasma exchange. SVPE is the repeated removal of small volumes of supernatant plasma over several days via sedimentation of patient whole blood. The aim of this study is to define the clinical feasibility and safety of SVPE in patients with GBS in resource poor settings.
A total of 20 adult patients with GBS will be enrolled for SVPE at a single center in Bangladesh. Six daily sessions of whole blood sedimentation and plasma removal will be performed in all patients with GBS with a target to remove an overall volume of at least 8 liters (L) of plasma over a total of 8 days. Serious adverse events (SAE) are defined as the number of patients developing severe sepsis associated with the central venous catheter or deep venous thrombosis in the limb where the catheter is placed for SVPE. Based upon a predictive success rate of 75%, the SVPE procedure will be considered safe if less than 5 of 20 SVPE-treated GBS patients have a SAE. The procedure will be considered feasible if 8 L of plasma can be removed in at least 15 of 20 patients with GBS who receive SVPE. In addition, detailed clinical and neurological outcome assessments will be performed until discharge of the patient from the hospital and up to 4 weeks after study entry.
This is the first clinical study to evaluate the feasibility and safety of SVPE as a potential alternative low-cost treatment for the patients with GBS in resource poor settings.
Clinicaltrials.gov NCT02780570.
在孟加拉国，大多数吉兰-巴雷综合征（GBS）患者负担不起静脉注射免疫球蛋白（IVIG）的标准治疗或标准血浆置换（PE）疗程，这在一定程度上解释了该国GBS相关的高死亡率和残留残疾率。小容量血浆置换（SVPE）是一种经济实惠且可能有效的血浆置换替代形式。SVPE是通过患者全血沉降在数天内反复去除少量上清血浆。本研究的目的是确定在资源匮乏地区GBS患者中SVPE的临床可行性和安全性。
共有20例成年GBS患者将在孟加拉国的一个单一中心接受SVPE治疗。所有GBS患者将进行6次全血沉降和血浆去除的每日疗程，目标是在总共8天内至少去除8升（L）血浆。严重不良事件（SAE）定义为发生与中心静脉导管相关的严重脓毒症或在放置用于SVPE导管的肢体发生深静脉血栓形成的患者数量。基于75%的预测成功率，如果20例接受SVPE治疗的GBS患者中少于5例发生SAE，则SVPE程序将被认为是安全的。如果20例接受SVPE的GBS患者中至少15例能够去除8L血浆，则该程序将被认为是可行的。此外，将进行详细的临床和神经学结局评估，直至患者出院以及研究入组后4周。
这是第一项评估SVPE作为资源匮乏地区GBS患者潜在替代低成本治疗的可行性和安全性的临床研究。
Clinicaltrials.gov NCT02780570。
