After inclusion and exclusion criteria implementation, patients will be selected. after the consent taking, ferritin levels will be measured and recorded.
Patients will be divided in 2 groups randomly. In first group (case) intravenous and in second group (control) subcutaneous desferal administration will be performed for a week, 200 mg/kg/day.
After the treatment period, serum ferritin levels will be measured again and a week later, echocardiography was also performed. All data will be recorded and then analyzed. After final analysis, the results will be announced.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206289827N2
Registration date:2012-07-14, 1391/04/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-14, 1391/04/24
Registrant information
Name
Afshin Safari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Sevices
Country
Iran (Islamic Republic of)
Phone
+98 83 1836 7398
Email address
mehramini143@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Kermanshah University of Medical Sciences and Health Services.
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of intravenous and subcutaneous high-dose desferal on Iron overload in thalassemia major patient with decrease in Ejection-Fraction.
Public title
Comparison of two methods of administration of deferoxamine (intravenous and subcutaneous) in terms of impact on reducing iron overload in thalassemia patients who have suffered heart failure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering major Thalassemia and cardiac ejection fraction less than 50%.
Exclusion criteria: inflammatory disease; anemia and liver disorders.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
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
Kermanshah University of Medical Sciences and Health Services
Street address
Research Council of Kermanshah University of Medical Sciences and Health Services, No2 Building, Shahid-Beheshti Blvd, Kermanshah.
City
Kermanshah
Postal code
6714858773
Approval date
2011-10-23, 1390/08/01
Ethics committee reference number
7730
Health conditions studied
1
Description of health condition studied
Iron overload.
ICD-10 code
R79.0
ICD-10 code description
Abnormal level of blood mineral.
Primary outcomes
1
Description
Serum ferritin
Timepoint
1 week after intervention (desferal administration)
Method of measurement
Use of ELISA method, unit will be mg/L
Secondary outcomes
1
Description
Cardiac Ejection Fraction.
Timepoint
2 weeks after intervention.
Method of measurement
Using Ecocardiography, the unit will be "percent"
Intervention groups
1
Description
Case Group: Desferal (Desferrioxamine Mesylate 500mg) intravenous administration will be performed for a week, 200 mg/kg/day.
Category
Treatment - Drugs
2
Description
Control group:Desferal (Desferrioxamine Mesylate 500mg) subcutaneous administration will be performed for a week, 200 mg/kg/day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia Center of Dr Mohamad Kermanshahi Hospital.
Full name of responsible person
Khosro Karimi
Street address
Dr Mohamad Kermanshahi Hospital, Rafatie St, Kermanshah.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Research Council of Kermanshah University of Medical Sciences and Health Services, No2 Building, Shahid-Beheshti Blvd, Kermanshah.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences and Health Services
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
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Khosro Karimi
Position
Intern (Medical student)
Other areas of specialty/work
Street address
Pediatrics Department of Imam-Reza Hospital, Sorkhelijhe, Kermanshah.
City
Kermabshah
Postal code
6714858773
Phone
+98 83 1427 6302
Fax
+98 83 1427 6316
Email
mehramini143@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohamadreza Golpaygani
Position
Hematology and Oncology Subspecialist
Other areas of specialty/work
Street address
Pediatrics Department of Imam-Reza Hospital, Sorkhelijhe, Kermanshah.
City
Kermanshah
Postal code
6714758773
Phone
+98 83 1427 6302
Fax
+98 83 1427 6316
Email
mehramini143@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Khosro Karimi
Position
Intern (Medical Student)
Other areas of specialty/work
Street address
Pediatrics Department of Imam-Reza Hospital, Sorkhelijhe, Kermanshah.
City
Kermanshah
Postal code
6714858773
Phone
+98 83 1427 6302
Fax
Email
mehramini143@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)