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| Name | Class |
|---|---|
| Al Mouwasat Hospital | OTHER |
| Al-Assad University Hospital | OTHER |
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This study compares the clinical effectiveness of Intravenous Immunoglobulin (IVIG) versus Plasma Exchange (PLEX) in patients experiencing a myasthenic crisis. Clinical response is evaluated 14 days post-treatment using the Quantitative Myasthenia Gravis Score (QMG). Additionally, the study aims to identify and report common precipitating factors for myasthenic attacks, such as respiratory infections or surgical stress.
This open-label prospective study evaluates patients at Al-Mouwasat and Al-Assad University Hospitals in Damascus, Syria. Participants include adult patients diagnosed with Myasthenia Gravis (MG) based on clinical evaluation and confirmed via repetitive nerve stimulation (RNS) or single-fiber electromyography (SFEMG).
Participants are assigned to two treatment groups based on the availability of medical supplies at the time of admission: the IVIG group and the PLEX group. The IVIG group receives a total dosage of 2 g/kg administered over 2 to 5 consecutive days. The PLEX group undergoes a series of up to five plasma exchange sessions.
The primary objective is to evaluate the change in the Quantitative Myasthenia Gravis Score (QMG) from baseline (Day 0) to 14 days post-treatment. The study also documents precipitating triggers for myasthenic attacks. Statistical analysis is performed using SPSS version 25.0, utilizing T-tests for continuous variables and Chi-Squared tests for categorical variables to compare the treatment methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG Group | Experimental | Participants in this group receive Intravenous Immunoglobulin (IVIG) at a total therapeutic dose of 2 g/kg body weight. The dose is administered intravenously over a period of 2 to 5 consecutive days. Clinical improvement is monitored using the Quantitative Myasthenia Gravis (QMG) scale. |
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| PLEX Group | Active Comparator | Participants in this group undergo therapeutic plasma exchange (PLEX) sessions. The protocol typically involves 5 sessions, performed every other day, to remove circulating antibodies. This group serves as the active comparator to evaluate the clinical response to treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG (Intravenous Immunoglobulin) | Biological | Patients receive Intravenous Immunoglobulin (IVIG) at a total dose of 2 g/kg body weight. The dose is divided over a period of 2 to 5 consecutive days administered intravenously |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score | The QMG is a validated physician-rated instrument consisting of 13 items that assess ocular, bulbar, respiratory, and limb muscle strength. Total scores range from 0 to 39, where higher scores represent greater clinical impairment. Clinical improvement is defined as a reduction in the mean QMG score from baseline. | Day 14 post-initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Anti-AChR Antibodies. | Evaluation of the frequency of positive anti-acetylcholine receptor (AChR) antibodies among the study population to assess its correlation with the severity of the myasthenic crisis. | Day 14 post-treatment |
| Frequency of Myasthenic Crisis Triggers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Shehadeh Agha, MD, PhD | Damascus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damascus University | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23956564 | Result | Sharma S, Lal V, Prabhakar S, Agarwal R. Clinical profile and outcome of myasthenic crisis in a tertiary care hospital: A prospective study. Ann Indian Acad Neurol. 2013 Apr;16(2):203-7. doi: 10.4103/0972-2327.112466. | |
| 28916122 | Result | Roper J, Fleming ME, Long B, Koyfman A. Myasthenia Gravis and Crisis: Evaluation and Management in the Emergency Department. J Emerg Med. 2017 Dec;53(6):843-853. doi: 10.1016/j.jemermed.2017.06.009. Epub 2017 Sep 12. |
| Label | URL |
|---|---|
| Study Protocol and Statistical Analysis Plan on OSF | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 10.17605/OSF.IO/PKTSJ | Study Protocol | View IPD |
Individual participant data (IPD) will not be shared with other researchers to maintain patient confidentiality and privacy, as per local institutional regulations
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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A prospective, non-randomized, parallel-group study comparing the efficacy of IVIG versus Plasma Exchange in patients with Myasthenic Crisis.
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None (open Lable)
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| Plasma exchange (PE) | Procedure | Patients undergo therapeutic plasma exchange (PLEX), typically consisting of 5 sessions performed every other day., with a replacement volume of 1 to 1.5 plasma volumes per session. |
|
Identification and categorization of the most common factors leading to myasthenic crisis, such as respiratory infections or surgical stress. |
| Through hospital discharge, average 14 days |
| 39376877 | Result | Zain A, Akram MS, Ashfaq F, Ans A, Ans HH. Comparative Analysis of Intravenous Immunoglobulins (IVIg) vs Plasmapheresis (PLEX) in the Management of Myasthenic Crisis. Cureus. 2024 Sep 7;16(9):e68895. doi: 10.7759/cureus.68895. eCollection 2024 Sep. |
| 27358333 | Result | Sanders DB, Wolfe GI, Benatar M, Evoli A, Gilhus NE, Illa I, Kuntz N, Massey JM, Melms A, Murai H, Nicolle M, Palace J, Richman DP, Verschuuren J, Narayanaswami P. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016 Jul 26;87(4):419-25. doi: 10.1212/WNL.0000000000002790. Epub 2016 Jun 29. |
| 21670440 | Result | Raz N, Dotan S, Benoliel T, Chokron S, Ben-Hur T, Levin N. Sustained motion perception deficit following optic neuritis: Behavioral and cortical evidence. Neurology. 2011 Jun 14;76(24):2103-11. doi: 10.1212/WNL.0b013e31821f4602. |
| 23235588 | Result | Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD002277. doi: 10.1002/14651858.CD002277.pub4. |
The study protocol is registered on the OSF platform for transparency and documentation. |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |