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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2014071718517N1 |
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Date of registration:
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2014-09-12 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The efficacy of erythropoietin in the treatment of anemia in patients hospitalized in Intensive Care Unit(ICU)
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Scientific title:
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The efficacy of erythropoietin in the treatment of anemia in ICU patients |
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Date of first enrolment:
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2014-02-20 |
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Target sample size:
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70 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/16772 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: After selection of patients, subjects will be divided randomized into two groups( case and control)according to admission document number.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Asghar Pirzadeh
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Address:
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Imam Khumeini Hospital, Shahid Sarhang Ghafour Jeddi street, Ardabil
Ardabil
Iran (Islamic Republic of) |
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Telephone:
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+98 45332251401 |
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Email:
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emamhe@arums.ac.ir |
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Affiliation:
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Ardabil University of Medical Sciences and health services |
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Name:
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Iraj Feizi
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Address:
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Fatemi hospital, Shariati square
56147
Ardabil
Iran (Islamic Republic of) |
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Telephone:
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+98 45332232520 |
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Email:
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i.feizi@arums.ac.ir |
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Affiliation:
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Ardabil University of Medical Sciences and health services |
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Key inclusion & exclusion criteria
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Inclusion 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
Exclusion criteria:
Age minimum:
18 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anaemia.
Anaemia, unspecified
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Anaemia, unspecified
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Intervention(s)
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Control group: Packed cell, 1 International Unit, intra venus, if hemoglobin below 7, during admission
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Intervention 1: 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. Intervention 2: Control group: Packed cell, 1 International Unit, intra venus, if hemoglobin below 7, during admission.
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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
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Treatment - Drugs
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Primary Outcome(s)
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Hemoglobin. Timepoint: Before the intervention, daily until discharge or death. Method of measurement: with Complete blood cell count.
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Secondary Outcome(s)
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Blood pressure. Timepoint: Daily. Method of measurement: mmHg with barometer.
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Source(s) of Monetary Support
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Vice Chancellor for research of Ardabil University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Ardabil University of Medical Sciences and health services
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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