Comparison of the effect and Complications of Failure to do Plasmapheresis Versus Routine Plasmapheresis in Patients with Myasthenia Gravis Candidate for Thymectomy
Comparison of the Effect of Complications of Failure to do Plasmapheresis Versus Routine Plasmapheresis in Patients with Myasthenia Gravis Candidate for Thymectomy
Design
randomization is not done. this study is single blinded with historical controls that analyzer is blinded and conducted in 80 participants and including two groups of intervention ( not perform Plasmapheresis group) and control (Plasmapheresis group) groups
Settings and conduct
In this study myasthenia gravis patients which have inclusion criteria are enrolled to the study and they are undergoing thymectomy with the open method or thoracoscopic and the results is compared to control group that went under Plasmapheresis befor surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All members of the ossermanI, IIA and IIB groups who are candidate for thymectomy
Exclusion criteria: Need to plasmapheresis before the surgery
Patient dissatisfaction to entering the study
Intervention groups
Intervention group is the Patients with Myasthenia Gravis Candidate for Thymectomy that receive Failure to do Plasmapheresis intervention
control group is the Patients with Myasthenia Gravis Candidate for Thymectomy that receive Plasmapheresis intervention
Main outcome variables
Blood volume, Duration of admission in ICU, Duration of admission in the ward
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190205042629N1
Registration date:2019-05-25, 1398/03/04
Registration timing:registered_while_recruiting
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Yousef Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2753
Email address
yousefiy961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect and Complications of Failure to do Plasmapheresis Versus Routine Plasmapheresis in Patients with Myasthenia Gravis Candidate for Thymectomy
Public title
Comparison of the effect and Complications of Failure to do Plasmapheresis in Patients with Myasthenia Gravis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All members of the ossermanI, IIA and IIB groups who are candidate for thymectomy
Exclusion criteria:
Need to plasmapheresis before the surgery
Patient dissatisfaction to entering the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-01-27, 1397/11/07
Ethics committee reference number
IR.Mums.medical.rec.1397.516
Health conditions studied
1
Description of health condition studied
Myasthenia Gravis
ICD-10 code
G70.0
ICD-10 code description
Myasthenia gravis
Primary outcomes
1
Description
Blood volume
Timepoint
after surgery
Method of measurement
Collecting the amount of blood in the surgery
2
Description
Duration of admission in ICU
Timepoint
after surgery
Method of measurement
Total number of days hospitalized
3
Description
Duration of admission in the bard
Timepoint
after surgery
Method of measurement
Total number of days hospitalized
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Yousef Yousefi
Street address
Ahmad Abad ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
0098
Phone
+98 51 3801 2753
Email
yousefiy961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Bagheri
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ahmad Abad ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2753
Email
yousefiy961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2753
Email
bagherir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Yousef
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2753
Email
YousefiY961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month