Objectives: evaluating the consumption of human recombinant Erythropietin in anemic patients diagnosed with solid insitu tumor to reduce the need for blood transfusions and referring to clinic
Design:Population being studied: hospitalised patients in the Hematology ward with solid insitu tumor,the volume of the sample:60 patients, randomized controlled trial,not blinded,one-centered
Setting and conduct: Sixty hospitalised patients in the Hematology ward with solid insitu tumor were divided into 2 case and control groups. Patients in case group-including 30 patients-will receive Erythropoietin 450 IU/kg subcutaneously once in a week,for 12 weeks.
Main inclusion criteria: hospitalised patients in the Hematology ward beneath 15 years of age,with solid insitu tumor and no bone marrow involvement
Main exclusion criteria: Erythropoietin side effects
The intervention being studied: Using human recombinant Erythropoietin
Duration of intervention:1 year
Primary outcome measures:Increase in Hemoglobin, the numbers and volume of blood transfusions
Secondary outcome measures:the numbers of referring to the clinic
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061822805N1
Registration date:2015-08-22, 1394/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-22, 1394/05/31
Registrant information
Name
Amir Ataollah Hiradfar
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2251
Email address
hiradfara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficiency of recombinant human erythropoietin in reducing the need for blood transfusions in patients with solid tumors receiving chemotherapy.
Public title
The benefits of Erythropoietin in reducing the need for blood transfusions in patients receiving chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of the patients, entering the study, should be beneath 15 years; The amount of Hemoglobin should be below 10 g/dL(gram per deciliter); Patients who are anemic due to chemotherapy, after they are diagnosed with solid insitu tumor; None of the patients have bone marrow involvement; Patients entering the study have normal kidney,liver,and lung function; Normal amounts of other blood-related parameters including retic.count, Serum ferritin, B12 vitamin in the serum, direct and indirect coombs tests, and ABG(Arterial Blood Gas); No history of blood transfusions in the last 1 month; No history of Erythropoietin consumption
Exclusion criteria: Severe bleeding during the study; Hemolysis during the study due to any causes; The evidence of existing imapirment in kidney,liver,and lung function; Evidence of any serious side effects of Erythropoietin including thrombosis, increased systemic blood pressure, and polycythemia
Age
From 1 year old to 15 years old
Gender
Both
Phase
1-2
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
Randomization was carried out by the random numbers chart.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research and Technology deputy, third floor, central building number 2, Tabriz University of Medical Sciences,Golgasht street
City
Tabriz
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
tbzmed.rec.1394.164
Health conditions studied
1
Description of health condition studied
solid insitu tumor of the body
ICD-10 code
D00-D09
ICD-10 code description
In situ neoplasms
Primary outcomes
1
Description
The amount of hemoglobin increase
Timepoint
Weekly, until the end of the treatment
Method of measurement
g/dL(gram per deciliter) in blood tests
2
Description
The numbers and volume of blood transfusions
Timepoint
weekly blood test(hemoglobin amounts;transfusion of 10 ml/kg when hemoglobin is under 7 ml/dl)
Method of measurement
Based on patients' hemoglobin and in mililiter
Secondary outcomes
1
Description
the numbers of referring to the clinic
Timepoint
weekly
Method of measurement
using their clinic files
Intervention groups
1
Description
Control group: Patients who receive only common chemotherapy agents without human recombinant Erythropoietin
Category
Treatment - Drugs
2
Description
Intervention group: Anemic patients due to chemotherapy, receiving human recombinant Erythropoietin,450 units per kilogram, Subcutaneously once in week for 12 weeks
Manufacturer company: Pooyesh Darou Biopharmaceutical co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's hospital
Full name of responsible person
Amir Ataollah Hiradfar
Street address
Children's hospital, Sheshgelan street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Amir Ataollah Hiradfar
Street address
Central building of Tabriz University of Medical Sciences, Golgasht street, Azadi street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz 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
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Amir ataollah hiradfar
Position
Pediatrician,Subspecialist in Hematology and Oncology
Other areas of specialty/work
Street address
Children's hospital, Sheshgelan street
City
Tabriz
Postal code
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
hiradfarataollah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Amir Ataollah Hiradfar
Position
Pediatrician, Subspecialist in Hematology and Oncology
Other areas of specialty/work
Street address
Children's hospital, Sheshgelan street
City
Tabriz
Postal code
Phone
+98 41 3526 2265
Fax
Email
hiradfarataollah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Amir Ataollah Hiradfar
Position
Pediatrician,Subspecialist in Hematology and Oncology
Other areas of specialty/work
Street address
Children's hospital,Sheshgelan street
City
Tabriz
Postal code
Phone
+98 41 3526 2265
Fax
Email
hiradfarataollah@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)