Title: Comparing the high-dose dexamethasone effect versus prednisolone in treatment of immune thrombocytopenic purpura patients
Design
Clinical trial without control group, with parallel groups, without blind and non-random, phase 3 on 36 patients
Settings and conduct
All patients aged 18 years old with immune thrombocytopenic purpura (ITP) who were admitted to the oncology of Imam Khomeini Hospital in Urmia and have not previously been treated
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with ITP, which are newly diagnosed and have been treated and previously no therapies
Exclusion criteria:People with life-threatening bleeding such as brain hemorrhage;People with trauma;People who have recent surgery
Intervention groups
Patients with ITP, which are newly diagnosed and have been treated and previously no therapies that it two separate groups are treated with intravenous dexamethasone or oral prednisolone.
Main outcome variables
Duration of admission ; Time to reach a platelet response above thirty thousand
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211111053039N1
Registration date:2022-01-24, 1400/11/04
Registration timing:registered_while_recruiting
Last update:2022-01-24, 1400/11/04
Update count:0
Registration date
2022-01-24, 1400/11/04
Registrant information
Name
fatemeh zahmatyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9856
Email address
zahmatyar.f@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the high-dose dexamethasone effect versus prednisolone in treatment of immune thrombocytopenic purpura patients
Public title
Comparing the high-dose dexamethasone effect versus prednisolone in treatment of immune thrombocytopenic purpura patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ITP, which are newly diagnosed and have been treated and previously no therapies
Exclusion criteria:
People with life-threatening bleeding such as brain hemorrhage
People with trauma
People who have recent surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of URMIA University of Medical Sciences
Street address
Emergency Alley, Resalat Blvd
City
URMIA
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-06, 1400/08/15
Ethics committee reference number
IR.UMSU.REC.1400.293
Health conditions studied
1
Description of health condition studied
Immune thrombocytopenic purpura
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
platelets count
Timepoint
daily
Method of measurement
complete blood count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: dexamethasone intravenous 40 mg daily to 4 days
Category
Treatment - Drugs
2
Description
Intervention group: edible prednisolone of 1 mg/kg body weight daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Fatemeh Zahmatyar
Street address
Imam Khomeini Hospital. Ershad Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3198 8001
Email
zahmatyar.f@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Emergency Alleyway . Resalat Blvd.Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۴۷۸۳۷۳۴
Phone
+98 44 3223 4897
Email
sabergholizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Zahmatyar
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid Azari Alley.Taavon 2 Street. Ahandust Blvd
City
Urmia
Province
West Azarbaijan
Postal code
۱۱۱۱۱۱۱۱۱۱
Phone
+98 44 3346 9856
Email
zahmatyar.f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Zahmatyar
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid azari ave, taavon2 st, ahandoost Blvd, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
۱۱۱۱۱۱۱۱۱۱
Phone
+98 44 3346 9856
Email
zahmatyar.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Zahmatyar
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid azari ave, taavon2 st, ahandoost Blvd, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
۱۱۱۱۱۱۱۱۱۱
Phone
+98 44 3346 9856
Fax
Email
zahmatyar.f@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available