The aim of this study is to determine the effect of deferiprone-deferoxamine on cardiac function of patients with major thalassemia . Inclusion criteria are treating with iron chelators subcutaneous deferoxamine to 5 nights a week (with a dose of 50-30 micrograms per kilogram) for 3 years and exclusion criteria are gastrointestinal complications, failure to cooperate in the control tests (ALT, CBC) and becoming tired of the traffic for controlling consumption of deferiprone. 12 patients with beta major thalassemia referred to Gorgan Taleghani Hospital that were treated by subcutaneous deferoxamine with a dose of 30-50 mg/kg for 5 nights a week for 3 years , chocardiography will be done for them and LVEF (The amount of blood that comes out every beat of the heart) and serum ferritin will be determined. Then these patients are treated by deferiprone with dosage of 50-100 mg/kg daily and dferoxamine with dosage of 30-50 mg/kg for 3 nights a week for 3 years. At the end of each year, echocardiography is performed and LVEF and serum ferritin are determined for patients. Finally, The LVEF and serum ferritin values obtained within three years will be compared with baseline values.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070512765N4
Registration date:2014-08-08, 1393/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-08, 1393/05/17
Registrant information
Name
Azam Rashidbaghan
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1232 8539
Email address
hocr@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2010-02-23, 1388/12/04
Expected recruitment end date
2013-03-18, 1391/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial in evaluation of the efficacy of defroxamine-deferiprone on cardiac function in patients with major thalassemia
Public title
Evaluation of the efficacy of defroxamine- deferiprone on cardiac function in patients with thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients were treated with iron chelators Subcutaneous Deferoxamine with a doseof 30-50 mg/kg for 5 nights a week for 3 years before starting the study. Exclusion criteria: gastrointestinal complications; failure to cooperate in the control tests (ALT, CBC); becoming tired of the traffic for controlling consumption of deferiprone
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Falsafi Higher Education Bilding, Bigining of Shastkola Roade
City
Gorgan
Postal code
Approval date
2010-02-21, 1388/12/02
Ethics committee reference number
3817138812022
Health conditions studied
1
Description of health condition studied
Thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia major
Primary outcomes
1
Description
Left Venticular Ejection Fraction
Timepoint
It is messured for 3 years at the end of each year.
Method of measurement
Echocardiography
2
Description
Srum ferritin
Timepoint
It is messured for 3 years at the end of each year.
Method of measurement
Determining the level of serum ferritin by related test
Secondary outcomes
empty
Intervention groups
1
Description
Treatment by Deferiprone with a dose of 50-100 mg/kg daily associated with treatment by Deferoxamine with a dose of 50-30 mg/kg for 3 nights weekly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology and Oncology Research Center
Full name of responsible person
Narges beigom Mirbehbahani
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Masoud Khoshnia
Street address
Falsafi Higher Education Bilding, Bigining of Shastkola Roade
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Sciences
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
Hematology & Oncology Research Center, Golestan University of Medical Sciences
Full name of responsible person
Narges beigom Mirbehbahani
Position
Associate Professor
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Postal code
Phone
+98 17 1232 8539
Fax
+98 17 1232 8539
Email
n.mirbehbahani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology and Oncology Research Center, Golestan University of Medical Sciences
Full name of responsible person
Narges beigom Mirbehbahani
Position
Associate Professor
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Postal code
Phone
+98 17 1232 8539
Fax
+98 17 1232 8539
Email
n.mirbehbahani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hematology and Oncology Research Center, Golestan University of Medical Sciences
Full name of responsible person
Azam Rashibaghan
Position
MSc./ research expert of Hematology and Oncology Research Center
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Postal code
Phone
+98 17 1232 8539
Fax
+98 17 1232 8539
Email
rashidbaghan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)