Effect of preoperative erytropoetin and Ferinject injection on transfusion rate after adult cardiac surgery and comparing it with patients without erythropoietin and erythropoietin injection.
Effect of preoperative erytropoetin and Ferinject injection on transfusion rate after cardiac surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 100 patients. The Excel software was used for randomization.
Settings and conduct
In Modarres Hospital in tehran These patients are divided into two groups of 100 men and women. Anemia is considered to be less than 12 in women and less than 13 in men. and erythropoietin 5 _7 days before surgery, in hemoglobin less than 12
It is prescribed for female patients and less than 13 for men.And they are compared with 100 patients without erythropoietin injection and fringect in terms of the amount of blood injection.
Participants/Inclusion and exclusion criteria
Not allergic to iron tablets.liver disease .pediatric.iron overload
Intervention groups
Adults who undergo open heart surgery and receive intravenous iron, and control patients only receive blood transfusions in case of anemia.
Main outcome variables
Less blood consumption in heart surgery patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221021056256N1
Registration date:2022-11-26, 1401/09/05
Registration timing:registered_while_recruiting
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Alireza Omidi farzin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 549 9128
Email address
alirezaomidi661818@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative erytropoetin and Ferinject injection on transfusion rate after adult cardiac surgery and comparing it with patients without erythropoietin and erythropoietin injection.
Public title
Effect of erytropoetin and Ferinject on transfusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
These patients are divided into two groups, male and female. In the female group, hemoglobin is less than 12 and in the male group, hemoglobin is less than 13 is considered anemia.
Exclusion criteria:
History of allergy to iron.
liver disease
evidence of iron overload
pediatrics
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid Beheshty university of medical science
Street address
Modarres Hospital, Sadat abad Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1393845861
Approval date
2022-06-05, 1401/03/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.459
Health conditions studied
1
Description of health condition studied
Blood transfusion in heart surgery.
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia
Primary outcomes
1
Description
Frequency of blood transfusions.
Timepoint
5_7 day before surgery
Method of measurement
pack cell
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: injection of erytropoetin and ferinject
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Dr Ramin Baghaei Tehrani
Street address
Modarres Hospital, Sadat abad Ave, Tehran
City
Tehran
Province
Tehran
Postal code
13938458587
Phone
+98 21 2207 4090
Email
alirezaomidi661818@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Shahid Beheshty University
Full name of responsible person
Dr Ramin Baghaei Tehrani
Street address
Modarres Hospital, Saadat abad Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1393845861
Phone
+98 21 2207 4090
Email
alirezaomidi661818@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Shahid Beheshty University
Proportion provided by this source
10
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ramin Baghaei Tehrani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Modarres hospital, Sadat abad Ave , Tehran
City
Tehran
Province
Tehran
Postal code
1393845861
Phone
+98 21 2207 4090
Email
alirezaomidi661818@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ramin Baghaei Tehrani
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Modarres hospital, Sadat abad Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1393845861
Phone
+98 21 2207 4090
Email
alirezaomidi661818@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ramin Baghaei Tehrani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Modarres hospital, Sadat abad Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1393845861
Phone
+98 21 2207 4090
Email
alirezaomidi661818@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as the main result, can be published.
When the data will become available and for how long
6 mouth after publish
To whom data/document is available
for all
Under which criteria data/document could be used
for all is avaiable
From where data/document is obtainable
journal of published
What processes are involved for a request to access data/document