Protocol summary
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Study aim
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Determining the effect of Tranexamic acid drug in the prime solution of the cardiopulmonary bypass system on the amount of bleeding after surgery in open heart surgeries.
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Design
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This study is conducted in a double-blind manner and 60 patients are randomly divided into two control and intervention groups by the software.
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Settings and conduct
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The study is conducted in Yazd Heart Hospital. Patients, surgeons, nurses and perfusionists are not aware of which study group the patients are in.
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Participants/Inclusion and exclusion criteria
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People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery.
People older than 18 years
Patients who have coagulation problems before the operation are not included in the study.
platelet count less than 100,000/ml are not included in the study.
Patients whose CPB time is more than 90 minutes are not included in the study.
Patients with hemoglobin lower than 10 mg/dL are not included in the study
People with kidney failure
Hypersensitivity to tranexamic acid
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Intervention groups
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In the prime solution of the cardiopulmonary bypass device in the intervention group, tranexamic acid drug is used. But normal saline is used in the control group.
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Main outcome variables
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One of the most important side effects of open heart surgery is bleeding. If the results of this study are positive regarding the reduction of bleeding, this drug can be used in the prime solution of the cardiopulmonary bypass system in heart surgeries so that the bleeding complication reaches its minimum level and the patient's hemodynamics has a more stable condition, which ultimately reduces the death rate. and reduce the mortality of patients and various complications, including cardiac tamponade, coagulation disorders, etc.
General information
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Reason for update
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Typographical error
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240220061056N1
Registration date:
2024-05-14, 1403/02/25
Registration timing:
registered_while_recruiting
Last update:
2024-07-08, 1403/04/18
Update count:
1
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Registration date
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2024-05-14, 1403/02/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-03-28, 1403/01/09
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Expected recruitment end date
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2024-05-29, 1403/03/09
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of Tranexamic acid acid drug in the prime solution of the cardiopulmonary bypass system on the amount of bleeding after surgery in open heart surgeries.
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Public title
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Investigating the effect of Tranexamic acid drug in cardiopulmonary bypass device
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery.
Exclusion criteria:
under of 18 years
History of seizures before surgery
History of embolism before surgery
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The method of allocating the samples to the two study groups will be obtained by the permutation block method and by considering blocks of size 6 using the Random Allocation software where T represents the intervention group and P represents the control group.
PTPPTT,TTPPTP,TPPPTT,TPTTPP,TTTPPP,TPPPTT,TPPPTT,PTPTTP,TTPPPT,TPPTPT
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants do not know which intervention or control group they are in.
The surgeon, nurse and perfusionist involved in the treatment process do not know which group the patient belongs to.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-11, 1402/07/19
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Ethics committee reference number
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IR.SSU.MEDICINE.REC.1402.185
Health conditions studied
1
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Description of health condition studied
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Investigating the amount of bleeding in heart surgery
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ICD-10 code
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I50.9
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ICD-10 code description
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Heart failure, unspecified
Primary outcomes
1
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Description
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Bleeding rate after surgery
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Timepoint
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24 hours after the operation
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Method of measurement
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chest bottle blood volume
Intervention groups
1
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Description
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Intervention group: The use of tranexamic acid drug at a dose of 15 mg/kg as a single dose is injected into the prime solution of the cardiopulmonary bypass device before the start of cardiopulmonary bypass.
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Category
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Treatment - Drugs
2
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Description
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Control group: In the control group, only 10 cc of normal saline will be added to the prime solution of the cardiopulmonary bypass device as a placebo.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available