comparisons transfusion requirement before surgery
Design
in this clinical trial patients that Have inclusion criteria divided into 2 groups with 77 patients
patients in intravenous iron and erythropoeitin groups take
100 IU/kg erythropoeitin via IV bolus administration With 200 mg iron sucrose mixed with 100 ml normal saline iv for 1 h at 24 h before surgery
In Control Group no intervention was done
Settings and conduct
patient who candidate for CABG in Tehran Heart Center Hospital if have inclusion ctiteria
Participants/Inclusion and exclusion criteria
inclusion
patient over 18 years old who candidate for CABG if hemoglobin concentration less than 12 g/dl inwomen and less than 13 g/dl in men according to WorldHealth Organization criteria and have Iron deficiency anemia with this definition1-ferritin < 30 mcg/l 2-ferritin 30-100 mcg /l or TSAT<20% OR CRP>5 mg/l
Exclusion
Patients with uncontrolled hypertension (BP>180/110)-platelet count more than 450,000/mm3 history of thromboembolism, seizure, malignant disease, liver dysfunction, confirmed renal impairment (serum creatinine[Cr]2 mg/dl), aplastic or iron deficiency anemia and hypersensitivity to iron.history of erythropoeitin use
Intervention groups
we have 2 groups with 77 patient in each group Patients in the IV Iron and erythropoeitin group received 100 IU/kg erythropoeitin via
intravenous bolus administration at 24 h before surgery.
At the same time, 200 mg iron sucrose supplement mixed with
200 ml normal saline was administered intravenously for 1 h.
The patients in the control group received no Intervention
Main outcome variables
comparisons perioperative transfusion requirement and mean number of units of packed erythrocytes transfused per patient during the surgery and for 4 days after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042447N1
Registration date:2019-11-23, 1398/09/02
Registration timing:registered_while_recruiting
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Shima Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6608 6109
Email address
shima.jafariy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-04, 1398/02/14
Expected recruitment end date
2020-01-04, 1398/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Erythropoietin and Intravenous Iron on transfusion requirements in patients undergoing cardiac surgery
Public title
Evaluating the efficacy of Erythropoietin and Intravenous Iron on transfusion requirements in patients undergoing cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patient over 18 years old CABG candidate if hemoglobin concentration less than 12 g/dl in women and less than 13 g/dl in men 1-ferritin < 30 mcg/l 2-ferritin 30-100 mcg /l or TSAT<20% OR CRP>5 mg/l
Exclusion criteria:
Patients with uncontrolled hypertension (BP>180/110) -platelet count more than 450,000/mm3 history of thromboembolism, history of seizure, history of malignant disease liver dysfunction(transaminase>3ULN), confirmed renal impairment (serum creatinine[Cr]2 mg/dl), aplastic anemia hypersensitivity to iron history of erythropoeitin use
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
In this study,Permuted Block Randomization method was used individually.the randomized list of numbers 1 to 154 is randomely divided into two groups A or B,and the admitted patients are listed in group A or B,respectively.
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
Islamic Republic of Tehran University Of Medical SCIENCE
Street address
North Kargar street- jalal street-Tehran Heart Center Hospital
City
TEHRAN
Province
Tehran
Postal code
1937836814
Approval date
2019-07-18, 1398/04/27
Ethics committee reference number
IR.TUMS.TIPS.REC.1398.027
Health conditions studied
1
Description of health condition studied
iron deficiency anemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
transfusion requirement
Timepoint
before surgery until seven days after surgery
Method of measurement
transfused volume in mili litre
Secondary outcomes
1
Description
hemoglobin concentration changes
Timepoint
before surgery until seven days after surgery
Method of measurement
labaratory data in mg/dl
Intervention groups
1
Description
Intervention group: 77 patients with iron deficiency anemia give 100unit/kg erythropoeitin IV bolus with 200 mg iron sucrose in 200 ml normal salin iv infusion in 1 hours
Category
Treatment - Drugs
2
Description
Control group: no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Azita Haj Hossein Talasaz
Street address
north kargar street-jalal street-tehran heart center hospital
City
tehran
Province
Tehran
Postal code
1937836814
Phone
+98 21 2223 4214
Fax
Email
shima.jafariy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammad ali sahraeian
Street address
Vice Chancellor for research,Tehran Univercity of medical sciences,Ghods Ave,Tehran Iran
City
tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 7381 8898
Email
msahrai@sina.tums.ac.ir
Grant name
Mohammad ali sahraian
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
shima jafari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
tehran heart center hospital
City
tehran
Province
Tehran
Postal code
1343966544
Phone
+98 21 8802 9600
Email
shima.jafariy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shima jafari
Position
resident of clinical pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
north kargar street-jalal street-tehran heart center hospital
City
tehran
Province
Tehran
Postal code
1937836814
Phone
+98 21 2223 4214
Email
shima.jafariy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
azita haj hossein talasaz
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Heart center Hospital
City
Tehran
Province
Tehran
Postal code
1937836814
Phone
+98 21 6608 6109
Fax
Email
shima.jafariy@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
the last result and analytical data
When the data will become available and for how long
at the end of the work
To whom data/document is available
all reasearchers
Under which criteria data/document could be used
no criteria
From where data/document is obtainable
from email
What processes are involved for a request to access data/document
they should send email then we share our data with them