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Comparison of the effect of Intravenous immunoglobulin and rhophylac in treatment of immune thrombocytopenic purpura

Protocol summary

Summary
Objectives: Immune thrombocytopenic purpura is a bleeding disorder in children that is characterized by thrombocytopenia, petechiae and purpura. Different mechanisms are involved in the pathophysiology of this disease. In addition to peripheral platelet destruction, impaired platelet production and megakaryocyte apoptosis in bone marrow are also involved in the pathophysiology. Intravenous immunoglobulin (IVIG) is the common treatment of the disease but because of its high cost, the patient should be hospitalized for some days. Infusion time is at least eight hours and also numerous complications including aseptic meningitis may occur following consumption. In contrast, Rhophylac has the least complications. Its prescription does not need hospitalization and the maximum duration of infusion is 10 minutes. In this study we compare these two medications in treatment of immune thrombocytopenic purpura. Design: Intermittent randomization, without placebo, including sixty children with immune thrombocytopenic purpura. Participants including major eligibility criteria: All children of 1-15 ages with acute or chronic immune thrombocytopenic purpura who have platelet counts below thirty thousands at the time of treatment. Intervention: IVIG, 1 gr/kg, 8 hours IV infusion, single dose. Rhophylac, 50 µg/kg, 15 minutes IV infusion with 100 ml normal saline, single dose. Main outcome measures: Platelet count, fever, hemolysis, allergic reaction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012102811289N1
Registration date: 2013-12-13, 1392/09/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-13, 1392/09/22
Registrant information
Name
Peyman Azadmanesh
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3312 0180
Email address
dr.azadmanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
All costs of this project will be financed by the Arak University of Medical Sciences, Vice Chancellor for Research.
Expected recruitment start date
2012-08-05, 1391/05/15
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Intravenous immunoglobulin and rhophylac in treatment of immune thrombocytopenic purpura
Public title
Comparison of the effect of Intravenous immunoglobulin and rhophylac
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age upper 1 year and lower 15 years old in patients with acute or chronic ITP 2. Platelets <30000 at the time of treatment 3. Patients entered in the study that parental consent was obtained Exclusion criteria: 1. Splenectomy patients 2. Hemoglobin below 10 g/dL 3. Patients who have been treated with IVIG or rhophylac in the past three weeks 4. Patients with renal insufficiency 5. Total bilirubin above 2 mg per deciliter and higher than normal liver enzymes 6. Patients who have a positive direct Coombs test 7. Patients who are infected with HIV or hepatitis C or B 8. Patients with lupus erythematosus 9. Patients with cardiovascular disease 10. Rh-negative patients
Age
From 1 year old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will randomly and intermittently (based on the entry of patients into the study, intermittently) divide into two groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2012-10-06, 1391/07/15
Ethics committee reference number
91-131-2

Health conditions studied

1

Description of health condition studied
Idiopathic thrombocytopenic purpura
ICD-10 code
D69.3
ICD-10 code description
Idiopathic thrombocytopenic purpura (Evans syndrome)

Primary outcomes

1

Description
platelet count
Timepoint
Sixth hour and days 3, 7, and 14 after treatment
Method of measurement
complete blood count

2

Description
fever
Timepoint
since 6 hours after infusion
Method of measurement
mercury thermometer

3

Description
hemolysis
Timepoint
6 hours after infusion
Method of measurement
complete blood count

4

Description
allergic reaction
Timepoint
6 hours after infusion
Method of measurement
clinical manifestations

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1. IVIG, 1 gr/kg, 8 hours IV infusion, single dose.
Category
Treatment - Drugs

2

Description
Intervention 2. Rhophylac, 50 µg/kg, 15 minutes IV infusion with 100 ml normal saline, single dose.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
Dr Peyman Azadmanesh
Street address
Amirkabir Hospital. Parastar square. Arak. Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Peyman Azadmanesh
Position
Pediatric resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3312 0180
Fax
Email
dr.azadmanesh@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Peyman Azadmanesh
Position
General practitioner
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3312 0180
Fax
Email
dr.azadmanesh@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Peyman Azadmanesh
Position
pediatric resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3312 0180
Fax
Email
dr.azadmanesh@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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