Protocol summary

Study aim
Assessment of response to treatment in anemia (iron deficiency) after CABG in Adults
Design
This study is a before and after, non-Randomized, single blind clinical trial. After obtaining patient consent and the approval of the ethics committee and the selection based on the inclusion and exclusion criteria, patients enter the study.Each patient in this study is also in the control and intervention group. The number of study samples is 142 patients and the sample size is collected using available samples.
Settings and conduct
In this study, patients are first tested for ferritin, TIBC and reticulocytes. Oral therapy (ferrous sulfate) is started based on the results of experiments to treat iron deficiency anemia. The above tests are repeated one week later to evaluate the treatment. If the response to treatment is appropriate, the patient will be monitored once and up to three times a month for CBC, TIBC, ferritin, and reticulocytes. Injectable iron is used if the tests are not appropriate one week after the start of oral iron, and the same follow-up is performed quarterly.This study is being performed at Shahid Rajaei Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients are candidates for CABG for the first time Age between 18 until 72 years Exclusion criteria:Kidney disorders, Autoimmune diseases
Intervention groups
In this study, adult patients who have low hemoglobin after an CABG on the last day of their stay at the ICU are included in the study. First, the desired tests are taken from the patients and the patients enter the before phase of the intervention, and in the next step, after giving the pill or ferrosulfate ampoule according to the specified protocol, the next tests are taken and the patients enter the after phase of the intervention and the result is recorded.
Main outcome variables
Hemoglobin level, ferritin level, reticulocyte count

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170912036157N2
Registration date: 2020-05-19, 1399/02/30
Registration timing: registered_while_recruiting

Last update: 2020-05-19, 1399/02/30
Update count: 0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Ziae Totonchi
Name of organization / entity
IUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2153
Email address
totonchi@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of response to treatment in anemia (iron deficiency) after CABG in adults
Public title
Assessment of response to treatment in anemia (iron deficiency) after CABG in adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 until 72 years Patients are candidates for CABG for the first time Hemoglobin is less than 10 in women and less than 11 in men
Exclusion criteria:
History of previous surgery Kidney disorders Autoimmune diseases Bleeding disorders, Thalassemia
Age
From 18 years old to 72 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B. This helps the person's personal opinion not to affect the results.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.IUMS.FMD.REC.1399.078

Health conditions studied

1

Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease

Primary outcomes

1

Description
Hemoglobin level
Timepoint
Before and after treatment
Method of measurement
Blood test

Secondary outcomes

1

Description
ferritin level
Timepoint
Before and after treatment
Method of measurement
blood test

Intervention groups

1

Description
Intervention group: In this study, each patient is placed in the control group first and enters the intervention group after the intervention.First, patients are tested for ferritin, TIBC, and reticulocytes. Oral therapy (ferrous sulfate) 60 mg three times a day is started based on the results of experiments to treat iron deficiency anemia. The above tests are repeated one week later to evaluate the treatment. If the response to treatment is appropriate, the patient will be monitored once and up to three times a month for CBC, TIBC, ferritin, and reticulocytes. Injectable iron is used at a dose of 200 mg intravenously slowly over 2,5 minutes and five times at intervals of 14 days if the tests are not appropriate one week after the start of oral iron, and the same follow-up is performed quarterly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Zia Totonchi
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2392 2153
Email
ziya189@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motavalian
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2392 2153
Email
ziya189@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zia Totonchi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2392 2153
Email
ziya189@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zia Totonchi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2392 2153
Email
ziya189@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Minou Jolousi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2392 2153
Email
ziya189@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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