A Comparative evaluation between the efficacy of IVIG and Methylprednisolone in primery treatment of immune thrombocytopenic purpura in children: Randomized clinical trial
This study aimed to compare the effect of IVIG and corticosteroids in immune thrombocytopenic purpura (ITP). In this double-blind randomized clinical trial 44 patients with ITP between 6 months to 8 years who referred to Shafa Hospital and platelets are below 20,000 are evaluate and the patients who have underlying cause for thrombocytopenia will be excluded. The patients will be divided into two groups of 22 individuals, the first group will be treated with IVIG (2 gr / Kg / day) and the second group will be treated with methylprednisolone at a dose of 20mg / kg / day. Then, the platelets of patients in the second and fifth days after treatment will be measured, and the increase in platelet of the two groups will be compared as an index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121831456N1
Registration date:2017-05-04, 1396/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Ali Aminasnafi
Name of organization / entity
Ahvaz Jundishapour Juniversity of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 96133743284
Email address
aminasnafi-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Development of Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2017-03-15, 1395/12/25
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative evaluation between the efficacy of IVIG and Methylprednisolone in primery treatment of immune thrombocytopenic purpura in children: Randomized clinical trial
Public title
A Comparative evaluation between the efficacy of IVIG and Methylprednisolone in primery treatment of immune thrombocytopenic purpura in children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: platelet count less than 20 × 109/L (20,000/ L); Isolated thrombocytopenia; increase number of megacaryocytes in an otherwise normal bone marrow: :Exclusion criteria: Bone marrow transplant; Systemic Lupus Erythematous; Ant phospholipid Syndrome; Evans Syndrome; Leukemia; Myelophthisic Infiltration; Myelodysplasia; Aplastic Anemia
Age
From 6 months old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan،Ahvaz،Ahvaz Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
6135715794
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.549
Health conditions studied
1
Description of health condition studied
Idiopathic Thrombocytopenic Purpura
ICD-10 code
D69.3
ICD-10 code description
Evans Syndrome
Primary outcomes
1
Description
Blood Platelet
Timepoint
Two days after treatment . Five days after treatment
Method of measurement
Count of Platelets in blood microliter measured by Sysmex kx21
Secondary outcomes
empty
Intervention groups
1
Description
First group : Treatment by Intravenous Immunoglobulin (IVIG) , dosage 2gr/kg/day
Category
Treatment - Drugs
2
Description
Second group : Treatment by Methylprednisolone , dosage 20mg/kg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital of Ahvaz
Full name of responsible person
Babak Sandughchian Shotorbani
Street address
Post Box 3155،Golestan،Shafa Hospital،Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Development of Ahvaz Jundishapour university of Medical Sciences
Full name of responsible person
Behzad SHARIF MAKHMALZADEH
Street address
Deputy of Research and Development of Ahvaz Jundishapour University of Medicah Sciences،Shahre Daneshgahi،Golestan،Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Development of Ahvaz Jundishapour university of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Babak Sandoghchian Shotorbani
Position
Pediatric Specialist
Other areas of specialty/work
Street address
Post Box 3155،Shafa Hospital،Golestan،Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3283
Fax
Email
Dr.babaksand@yahoo.com; itc@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Deputy of Research and Development of Ahvaz Jundishapour University of Medicah Sciences
Full name of responsible person
Babak Sandoghchian Shotorbani
Position
Pediatric Specialist
Other areas of specialty/work
Street address
Deputy of Research and Development of Ahvaz Jundishapour University of Medicah Sciences،Shahre Daneshgahi،Golestan،Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 2414
Fax
Email
Dr.babaksand@yahoo.com; itc@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Babak Sandoghchian Shotorbani
Position
Pediatric specialist
Other areas of specialty/work
Street address
Post Box 3155،Shafa Hospital،Golestan،Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 2414
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)