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IRCT20190205042629N1 IRCT 2019-05-25 Mashhad University of Medical Sciences Comparison of the effect and Complications of Failure to do Plasmapheresis in Patients with Myasthenia Gravis Comparison of the effect and Complications of Failure to do Plasmapheresis Versus Routine Plasmapheresis in Patients with Myasthenia Gravis Candidate for Thymectomy 2019-04-21 anticipated 80 Complete https://irct.ir/trial/37421 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Blinding description: In this study only the analyzer is blinded to the study. The analyzer is not knowing which the case and control group is. N/A Myasthenia Gravis. Intervention 1: Intervention group: Failure to perform plasmapheresis which is a plasma extraction technique that allows for the removal of immunoglobulins and pro-inflammatory factors, such as cryoglobulins and lipoproteins, which are the cause of many diseases. The amount and frequency of plasma required in this situation are partly optional. extracted plasma is replaced with albumin and saline and It is estimated that 2 liters of plasma replacement will remove 80% of circulating antibodies, which will reduce acetylcholine antibody levels within 3-5 days. Intervention 2: Control group: plasmapheresis before the surgery which is a plasma extraction technique that allows for the removal of immunoglobulins and pro-inflammatory factors, such as cryoglobulins and lipoproteins, which are the cause of many diseases. The amount and frequency of plasma required in this situation are partly optional. extracted plasma is replaced with albumin and saline and It is estimated that 2 liters of plasma replacement will remove 80% of circulating antibodies, which will reduce acetylcholine antibody levels within 3-5 days. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published To whom: Data will be available for researchers in universities and other scientific institutes Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month Comments:
public Reza Bagheri
Ahmad Abad ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3801 2753 yousefiy961@mums.ac.ir Mashhad University of Medical Sciences scientific Reza
Ahmad Abad ave.
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3801 2753 bagherir@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All members of the ossermanI, IIA and IIB groups who are candidate for thymectomy no limit no limit Both Need to plasmapheresis before the surgery Patient dissatisfaction to entering the study G70.0 Myasthenia gravis Treatment - Other Treatment - Other Intervention group: Failure to perform plasmapheresis which is a plasma extraction technique that allows for the removal of immunoglobulins and pro-inflammatory factors, such as cryoglobulins and lipoproteins, which are the cause of many diseases. The amount and frequency of plasma required in this situation are partly optional. extracted plasma is replaced with albumin and saline and It is estimated that 2 liters of plasma replacement will remove 80% of circulating antibodies, which will reduce acetylcholine antibody levels within 3-5 days. Control group: plasmapheresis before the surgery which is a plasma extraction technique that allows for the removal of immunoglobulins and pro-inflammatory factors, such as cryoglobulins and lipoproteins, which are the cause of many diseases. The amount and frequency of plasma required in this situation are partly optional. extracted plasma is replaced with albumin and saline and It is estimated that 2 liters of plasma replacement will remove 80% of circulating antibodies, which will reduce acetylcholine antibody levels within 3-5 days. Blood volume. Timepoint: after surgery. Method of measurement: Collecting the amount of blood in the surgery. Duration of admission in ICU. Timepoint: after surgery. Method of measurement: Total number of days hospitalized. Duration of admission in the bard. Timepoint: after surgery. Method of measurement: Total number of days hospitalized. Mashhad University of Medical Sciences Approved 2019-01-27 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)