The aim of the study was to evaluate the efficacy of erythropoietin in the treatment of anemia in patients hospitalized in ICU. Our study is a randomized single- blind clinical study. In this study after selection of patients based on inclusion and exclusion criteria, their data will be formed as a check list.
Inclusion criteria; age of 18 and above, Hematocrite more than 38% , Hospitalization in ICU for more than 7 days
Exclusion criteria; Uncontrolled hypertension, Uncontrolled seizure, Grade 3 and above burns, Pregnancy or breast feeding, Dialysing patients, The possibility of discharge from the hospital in less than 48 hours, Pulmonary embolism, Deep Vein Thrombosis and Chronic hypercoagolopathy
The total volume of the study is 70 people in the 2 group of 35 people. In this study erythropoietin will be used to intervention group and packed cell in control group in case of hemoglobin below 7.
Hematological indexes and clinical status of patients will be evaluated and results will be analyzed by the statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071718517N1
Registration date:2014-09-12, 1393/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-12, 1393/06/21
Registrant information
Name
Majid Saraei
Name of organization / entity
Ardabil University of medical sciences and health servi
Country
Iran (Islamic Republic of)
Phone
+98 49 2214 2668
Email address
s.mostafapour@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-07-11, 1393/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of erythropoietin in the treatment of anemia in ICU patients
Public title
The efficacy of erythropoietin in the treatment of anemia in patients hospitalized in Intensive Care Unit(ICU)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; age of 18 and above, Hematocrite more than 38% , Hospitalization in ICU for more than 7 days
Exclusion criteria; Uncontrolled hypertension, Uncontrolled seizure, Grade 3 and above burns, Pregnancy or breast feeding, Dialysing patients, The possibility of discharge from the hospital in less than 48 hours, Pulmonary embolism, Deep Vein Thrombosis and Chronic hypercoagolopathy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After selection of patients, subjects will be divided randomized into two groups( case and control)according to admission document number.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences and health services
Street address
Ardabil University of medical sciences and health services, Daneshgah street
City
Ardabil
Postal code
5618953141
Approval date
2014-02-09, 1392/11/20
Ethics committee reference number
Arums.Rec.92.32
Health conditions studied
1
Description of health condition studied
Anaemia
ICD-10 code
D64.9
ICD-10 code description
Anaemia, unspecified
Primary outcomes
1
Description
Hemoglobin
Timepoint
Before the intervention, daily until discharge or death
Method of measurement
with Complete blood cell count
Secondary outcomes
1
Description
Blood pressure
Timepoint
Daily
Method of measurement
mmHg with barometer
Intervention groups
1
Description
Intervention group: Erythropoietin, 4000 international Unit per 1 ml, Subcutaneous, 3 times in week, until discharge or death, made in Pooyesh Darou Pharmaceutical co. Tehran
Category
Treatment - Drugs
2
Description
Control group: Packed cell, 1 International Unit, intra venus, if hemoglobin below 7, during admission