In this study, we investigated the efficacy and safety of RF ablation in hematological parameters (rise of Platelet and hemoglobin, need of blood transfusion) in patients with Thalassemia Intermedia (TI). Inclusion criteria was presence of Cooley’s anemia in patients and exclusion criteria was positive Coomb's test. RF ablation of spleen had been performed in 15 TI children under general anesthesia using a Cooltip Radionics RF probe. These patients have been regarded as RFA group. Nine patients with TI who underwent partial splenectomy during the last 3 years and another 14 patient group with TI who underwent total spelenectomy during 3 years prior to study, were also enrolled as the first and second control groups (CG1 and CG2).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712141738N1
Registration date:2009-05-29, 1388/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-29, 1388/03/08
Registrant information
Name
Mehdi Naderifar
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 3233
Email address
nabavia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2008-07-20, 1387/04/30
Expected recruitment end date
2009-01-20, 1387/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effectiveness of radiofrequency ablation in beta thalassemia patients, considering hematologic parameters
Public title
Investigation of effectiveness of radiofrequency ablation in beta thalassemia patients, considering hematologic parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:beta thalassemia
Exclusion criteria: positive direct or indirect coombs
Age
From 5 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics commitee
Street address
Shiraz University of Medical Scieces
City
Shiraz
Postal code
Approval date
2008-07-20, 1387/04/30
Ethics committee reference number
CT-87-4150
Health conditions studied
1
Description of health condition studied
Beta thalassemia
ICD-10 code
D56.1
ICD-10 code description
Cooley's anaemia
Primary outcomes
1
Description
Level of Hb
Timepoint
3 month follow-up period
Method of measurement
CBC
2
Description
Platelet count
Timepoint
3 month follow-up period
Method of measurement
CBC
Secondary outcomes
1
Description
Need to transfusion
Timepoint
3 months follow-up period
Method of measurement
transfusion volume and intervals
Intervention groups
1
Description
Radiofrequency ablation of spleen in beta thalassemia using Cooltip Radionics RF Probe.
Category
Other
2
Description
Partial splenectomy
Category
Treatment - Surgery
3
Description
Total splenectomy
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee Hospital
Full name of responsible person
Mehdi Naderifar
Street address
Radiology Ward, Namazee Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Street address
Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Naderifar
Position
Radiology resident
Other areas of specialty/work
Street address
Radiology Ward, Namazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 3233
Fax
+98 71 1647 3233
Email
mehdinaderifar2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
SUMS
Full name of responsible person
Ali Reza Rasekhi
Position
Associate Professor
Other areas of specialty/work
Street address
Radiology Ward, Namazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 3233
Fax
+98 71 1647 3233
Email
mehdinaderifar2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Naderifar
Position
Resident
Other areas of specialty/work
Street address
Radiology Ward, Namazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 3233
Fax
+98 71 1647 3233
Email
mehdinaderifar2000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)