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IRCT20221206056735N1 IRCT 2022-12-19 Shahid Beheshti University of Medical Sciences Evaluation of intravenous immunoglobulin versus corticosteroid in immune thrombocytopenic purpura Efficacy of a single dose of Intravenous immune globulin (IVIG) (0.8 gr/Kg) vs tab Prednisolone (2mg/Kg) in pediatric newly diagnosed Immune thrombocytopenia (ITP) 2023-01-21 anticipated 100 Complete https://irct.ir/trial/67343 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients included in the study will be entered in two blocks, one group will receive intravenous immunoglobulin and the other will receive corticosteroids. In block dividing, we will ensure that exactly the same number of participants enter both of our intervention groups in consecutive but equal time intervals. However, in this study, due to the use of two blocks, there will be no possibility of blinding the information of some participants. Randomization in this study is done by a researcher in a simple random method. In this way, every new patient included in the study will enter one of the intervention groups randomly (using a lion coin or a line) and the next participant will enter the opposite group. The advantage of this method is the uniform distribution of participants in both groups both in terms of time and causes that there are not more participants in a certain group in a certain period of time. Also, if there is a lack of sample size in the sampling interval, it guarantees the equal number of people in the two groups. 2-3 Immune thrombocytopenic purpura (ITP). Intervention 1: Intervention group: group receiving intravenous immunoglobulin: In this group, participants receive intravenous immunoglobulin at a dose of 0.8 mg per kilogram of the patient's weight naturally. The infusion will be done slowly and over at least 4 to 6 hours. Intervention 2: Intervention group: Corticosteroid group: In this group, the participants will receive corticosteroids in the form of prednisolone 2 mg per kilogramfor at least 7 days or more according to the patient's medical discretion. Yes - There is a plan to make this available What will be shared: The data of this article will be published in two ways. First of all, after the publication of the thesis of this article, it will be in the Research Vice-Chancellor of Shahid Beheshti University of Medical Sciences. Then an article from this data will be published in one of the domestic and foreign journals that will be available for public. When: There will be no time limit on data access. To whom: The data will be available for public access. Conditions: Data reanalysis will not be allowed under any circumstances. Where to obtain: To receive data and documents, send a message to the responsible author. Requests will only be answered via email. Applicants can send their application to the email address surgery1353@gmail.com. How to obtain: After sending the request to the responsible author's e-mail, he will review it in general. Then, if there is no conflict of interest, all authors and researchers of the project will be informed. If the team agrees, the data will be provided to the applicant. Comments:
public Masoud Khodaei
No28, kamal Ave, ghazzaghi Ave, Bagheri Superhighway, Tehranpars
Tehran Iran (Islamic Republic of) 1985717443 +98 21 7772 5483 Surgery1353@gmail.com Shahid Beheshti University of Medical Sciences scientific Masoud Khodaei
No28, kamal Ave, ghazzaghi Ave, Bagheri Superhighway, Tehranpars
Tehran Iran (Islamic Republic of) 1985717443 +98 21 7772 5483 Surgery1353@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age of participants between one month and 17 years diagnosis of ITP The patient's plasma platelets are less than 10,000 per deciliter 1 month 17 years Both Life-threatening bleeding History of splenectomy Any contraindications for receiving IVIG A history of receiving IVIG or corticosteroids in the last two weeks (platelets have not reached more than 50,000) Presence of co-morbidity such as sepsis Fever above 38.5 degrees Celsius Splenomegaly (the edge of the spleen two centimeters below the edge of the rib) Presence of disseminated intravascular coagulation (DIC) (i.e., fibrinogen < 1 along with elevated D-dimer) D69.3 Immune thrombocytopenic purpura Treatment - Drugs Treatment - Drugs Intervention group: group receiving intravenous immunoglobulin: In this group, participants receive intravenous immunoglobulin at a dose of 0.8 mg per kilogram of the patient's weight naturally. The infusion will be done slowly and over at least 4 to 6 hours. Intervention group: Corticosteroid group: In this group, the participants will receive corticosteroids in the form of prednisolone 2 mg per kilogramfor at least 7 days or more according to the patient's medical discretion. Platelet count. Timepoint: The platelet count will be measured within three intervals: 48 hours, 7 days and one month after IVIG injection. Method of measurement: Cell blood count. Bleeding symptoms. Timepoint: During hospitalization. Method of measurement: Questionnaire and physical examination by pediatric hematologist. Shahid Beheshti University of Medical Sciences Approved 2022-12-01 Ethics committee of Shahid Beheshti University of Medical Sciences Tehran, Velengak, Koodakyar st Tehran Tehran Iran (Islamic Republic of)