Investigating the efficacy of short-term oral prednisolone compared to a two-week period in the treatment of newly diagnosed immune thrombocytopenic patients
Design
A clinical trial with a control group and a parallel group, which phase 3 was conducted on 70 non-randomized patients.
Settings and conduct
Mofid Children's Hospital
Loghman Hakim Hospita
Participants/Inclusion and exclusion criteria
Patients who have suffered from immune thrombocytopenic disease in less than 3 months
Platelet count less than 20 x 109 per liter
Age between 1 month and 14 years
Intervention groups
Investigating the effect of short-term corticosteroids in patients with immune thrombocytopenia compared to the effect of long-term and two-week corticosteroids in these patients
Main outcome variables
The count of Platelets in patients one month after taking prednisolone for one week
The patients go into remission after taking one week of prednisolone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230718058831N1
Registration date:2023-10-28, 1402/08/06
Registration timing:retrospective
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
Khatere Tavajohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
khtavajohi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
2022-10-07, 1401/07/15
Actual recruitment end date
2023-07-11, 1402/04/20
Trial completion date
2023-07-11, 1402/04/20
Scientific title
Comparison of the Efficiency of Short-Term and Two-Week Oral Prednisolone Use to Manage Newly Diagnosed Immune Thrombocytopenia
Public title
short term prednisolon in itp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
childeren with acuteImmune Thrombocytopenia
Exclusion criteria:
Patients with active infections and septicemia
patients with positive antinuclear antibody
patients with Evans syndrome
Patients with chronic immune thrombocytopenia
Patients with positive glue culture
Age
From 1 month old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
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 Medical Students of Shahid Beheshti University of Medical Sciences
Street address
No 4 . four baharestan,pasdaran blvd,tehran town
City
Tehran
Province
Tehran
Postal code
1689887961
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.SBMU.MSP.REC.1402.177
Health conditions studied
1
Description of health condition studied
Treatment Patients with acute immune thrombocytopenia
ICD-10 code
D69.3
ICD-10 code description
Immune thrombocytopenic purpura
Primary outcomes
1
Description
Platelet count of patients after a short course of prednisolone
Timepoint
Comment on the number of blood platelets at different time points before the start and days 2, 7, 30 and 60 after the start of the treatment period
Method of measurement
Compelete blood count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The study is designed in the form of a coincidental and open label. All patients with a newly diagnosed immune thrombocytopenic condition were aged 1 month to 15 years and had a platelet count of less than 109 × 20 per liter after obtaining informed consent from the parent Sadfi ward group took cannde long short duration prednizolon diet With a daily dosing regimen of 2 mg/kg of oral prednisolone on days 1 to 7 without drug dose titration, platelets were weighed during treatment on days 3, 14 and 30 during blood cell count testing. Similarly, 2 months after the start of treatment, patients were examined and response to treatment was given. Patients could be excluded from the study in any time they chose.
Category
Treatment - Drugs
2
Description
Intervention group: The study is designed as a randomized and open label format. All patients with a newly diagnosed immune thrombocytopenic condition were aged 1 month to 15 years and had a blood platelet count of less than 109 × 20 per liter after obtaining parental consent The group was given two weeks of dietary prednisolone .. Patients' platelets were measured before the start of the appointment and registration period and drugs were measured in mg/kg2 on 14 days and then from days 14 to 21 doses and titration were performed. Platelet counts were performed on days 3, 14 and 30 during treatment. Similarly, 2 months after the start of treatment, patients were examined and response to treatment was given. Patients could be excluded from the study in any time they chose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children hospital
Full name of responsible person
Shamsollah Noori poor
Street address
Above hosseinieh ershad ,shariati blvd,tehran town
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshim Zarghi
Street address
No4 ,four Baharestan , Pasdaran blvd,Tehran town
City
https://fa.irct.ir/Tehran
Province
Tehran
Postal code
1689887961
Phone
+98 912 050 4872
Email
khtavajohi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khatere Tavajohi
Position
َAssociate
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No4 ,four baharestan,pasdaran blvd,tehran town
City
تهران
Province
Tehran
Postal code
1689887961
Phone
+98 912 050 4872
Email
khtavajohi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khatere Tavajohi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 4 ,ashkan,four baharestan,pasdaran blvd,tehran town
City
Tehran
Province
Tehran
Postal code
1689887961
Phone
+98 21 2222 7021
Fax
Email
Khtavajohi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khatere Tavajohi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 4 ,ashkan,four baharestan,pasdaran blvd,tehran town
City
Tehran
Province
Tehran
Postal code
1689887961
Phone
+98 21 2222 7021
Fax
Email
Khtavajohi@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
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
The data of the study includes the complete information of the patients and the course of the patients' tests, and after deidentifying the individuals, a part of the data that is related to the outcome of the study can be published.
When the data will become available and for how long
6 mounth after published
To whom data/document is available
For other researchers
Under which criteria data/document could be used
For reference in other studies
From where data/document is obtainable
with researcher khatere tavajohi
khtavajohi@gmail.com
What processes are involved for a request to access data/document
After submitting the request via email, information will be provided to them within 2 hours