Investigating the effect of tranexamic acid injection on the postoperative chest drainage output of CABG patients compared to the control group
Design
A clinical trial with a control group, with parallel and double-blind and randomized phase 4 groups will be conducted on 140 patients undergoing CABG. The website https/www.Randomization.com is used for random assignment. In order to hide random allocation, central randomization will be used.
Settings and conduct
The study will be conducted in the surgery department of Shahid Madras Hospital, Shahid Beheshti University of Medical Sciences. This study is done in a double blind way. Patients, caregivers, anesthesiologists, surgeons and operating room personnel are not informed about the type of study.
Participants/Inclusion and exclusion criteria
Entry criteria:
- Age range 18-60 years
- Patient concent
Non-entry criteria:
Suffering from chronic kidney disease
- Use of anticoagulants
Intervention groups
One gram of tranexamic acid will be injected before surgery to the intervention group, but not to the drug control group.
Main outcome variables
The amount of chest drainage of the patients after the operation will be the primary outcome and the transfusion during and after the operation will be the secondary outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230626058586N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Nasim Sohrabifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 229 6766
Email address
nasimsohrabifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of tranexamic acid injection on the postoperative chest drainage output of CABG patients compared to the control group
Public title
Investigating the effect of tranexamic acid on drainage output after CABG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Informed consent
Definite candidate for CABG
Exclusion criteria:
chronic kidney disease
taking anticoagulants
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The website https/www.Randomization.com is used for random assignment. In order to hide random allocation, central randomization will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is done in a double blind way. Patients, caregivers, anesthesiologists, surgeons and operating room personnel are not informed about the type of study.
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
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SBMU.MSP.REC.1401.424
Health conditions studied
1
Description of health condition studied
Coronary artery bypass grafting
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft
Primary outcomes
1
Description
Examining drainage level after CABG surgery. It can be easily evaluated by drainage collection bag and will be calculated in cc.
Timepoint
After the surgery and for one week, the total level of drainage will be checked.
Method of measurement
Collect the amount of drainage in the bag and record it.
Secondary outcomes
1
Description
Transfusion during and after surgery.
Timepoint
During surgery up to 24 hours after surgery.
Method of measurement
The number of blood bags injected into the patient.
Intervention groups
1
Description
Intervention group: Injection of one gram of tranexamic acid to the patient before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital,
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
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
1
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 Baghayi Tehrani
Position
faculty member (associate professor)
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital,
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Position
faculty member (associate professor)
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Position
faculty member (associate professor)
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on primary and secondary outcomes and patient demographics will be shared on the condition that patients remain anonymous.
When the data will become available and for how long
After printing the results of the study, it will be possible to access the data if the readers request from the responsible author.
To whom data/document is available
Anyone interested in research in this field.
Under which criteria data/document could be used
After the results of the study are published, the data will be made available to the researchers upon request from the corresponding author.
From where data/document is obtainable
corresponding author. Dr. Ramin Baghai Tehrani. Located in Shahid Modares Hospital. Department of cardiac surgery. To zip code 1998734383.
What processes are involved for a request to access data/document
Depending on the busyness of the corresponding author, the data will be delivered within a week.