Comparison of different doses of tranexamic acid on coronary perfusion
Design
Randomised, parallel group trial with blinded outcome assessment
Settings and conduct
Antifibrinolytics are common in cardiac surgeries. In some researches, higher doses of tranexamic acid have used for lowering of bleeding and transfusion. But in patients under CABG surgery, thrombosis and decreasing of perfusion in coronary arteries is a dangerous point. This trial will compare cardiac enzymes before and after CABG surgery in two different doses of tranexamic acid.
Participants/Inclusion and exclusion criteria
Inclusion: All patients under CABG surgery; EF> 40%; Age between 40 to 75 years
Exclusion: Tranexamic acid sensitivity; Convulsion history; Thromboembolic event history
Intervention groups
Patients undergoing CABG surgery are randomly divided into two groups. After induction of anesthesia, the control group receive tranexamic acid at the usual dose of 10 mg/ kg plus infusion 2 mg/ kg/ h until the end of the operation and the intervention group receive a higher dose of 25 mg/ kg plus infusion 5 mg/ kg/ h until the end of the operation.
Main outcome variables
Cardiac enzymes, including Creatine kinase-MB and troponin , are measured before and after surgery in the usual dose and high-dose tranexamic acid groups. Significant increase in enzymes in the high dose group can be attributed to the thrombogenic effects of this dose.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180724040575N3
Registration date:2020-09-29, 1399/07/08
Registration timing:retrospective
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
kamal fani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4095
Email address
kamalfani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different doses of tranexamic acid on coronary perfusion in patients undergoing coronary artery bypass graft surgery (CABG)
Public title
Effect of tranexamic acid on coronary perfusion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under CABG surgery
Ejection Fraction(EF) >40%
Exclusion criteria:
Tranexamic acid sensitivity
Convulsion history
Thromboembolic event history
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
2
Cardiac enzymes before and after surgery
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who go to the cardiac operating room from the beginning of sampling and meet the necessary criteria are included in the study. For assignment in intervention and control groups, simple randomization method is used with the help of random numbers(RAND) in Excel software. In cell A1, type the formula = RAND () * (120-1) +1. By confirming and dragging to A60, we have sixty random numbers between 1 and 120. These numbers are the rows of participants in the intervention group(high dose tranexamic acid). For each row of participants, a closed envelope is prepared by the researcher not present in the operating room, and with the arrival of each patient, the relevant envelope is opened by the project partner in the operating room and the designated group is determined
Blinding (investigator's opinion)
Double blinded
Blinding description
Consent for participation in the study is obtained from all patients, but the participants and data collector are blind about the study groups. The researcher and patient care team are aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Approval date
2018-03-20, 1396/12/29
Ethics committee reference number
IR.SBMU.RETECH.1396.720
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cardiac enzymes
Timepoint
Before and 24 hours after surgery
Method of measurement
Eliza method for cardiac enzymes measurment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing coronary artery bypass graft receiving a high dose of tranexamic acid. In this group, after induction of anesthesia, tranexamic acid drug made by Caspian Pharmaceutical Company (500 mg vial in 5 ml) at a dose of 25 mg / kg body weight by slow intravenous injection as a loading dose and then 5 mg / kg body weight It is given as an intravenous infusion as a maintenance dose until the end of the operation. Intravenous infusion is performed with the help of a pump syringe and the drug dissolved in a 50 ml syringe.
Category
Prevention
2
Description
Control group: Patients undergoing coronary artery bypass graft receiving a standard dose of tranexamic acid. In this group, after induction of anesthesia, tranexamic acid drug made by Caspian Pharmaceutical Company (500 mg in 5 ml) at a dose of 10 mg / kg body weight by slow intravenous injection as a loading dose and then 2 mg / kg body weight It is given as an intravenous infusion as a maintenance dose until the end of the operation. Intravenous infusion is performed with the help of a pump syringe and the drug dissolved in a 50 ml syringe.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Kamal Fani
Street address
Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Taleghani Hospital, Velenjak,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Hospital, Velenjak,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
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