Comparison of the effect of transxamic acid(TA) administration by two methods topical and continuous infusion on the rate of hemorrhage in children with congenital non-cyanotic heart disease after open heart surgery
Design
Clinical trial with parallel groups of one-blind, accidental, phase two, 50patients
Settings and conduct
children who are candidates for surgery to close Atrial or Ventricular or Atrio-ventricular septum defect with CPB in Shahid Chamran Heart Hospital of Isfahan University of Medical Sciences in 1398, which is one-Blind and random were divided into two groups of 25 people. Continuous infusion group of 50 mg per kg of TA from induction to closing the sternum and patients of topical, 50 mg per kg of TA that reached 20 ml with normal saline solution before closing the sternum, inside Pericardium was shed and the patient's median mediastan tubules were clamped for 20 min.
Participants/Inclusion and exclusion criteria
Entry conditions for children under 14 kg and over 6 kg who are undergoing heart surgery for the first time with non-cyanotic heart disease correction with cardiopulmonary bypass(CPB), Clamp Aort time between 60 to 90 minutes and CPB time between 60 to 180 minutes and hemoglobin(HB) above 8 mg per deciliter before surgery
Conditions for non-entry of HB below 8 mg per deciliter before surgery, active non-counterfeit disease affecting postoperative recovery such as severe coagulation disorders, hemophilia, etc.
Intervention groups
Prescribing TA in both topical and infusion methods to reduce bleeding
Main outcome variables
Hemoglobin changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200429047236N1
Registration date:2020-05-12, 1399/02/23
Registration timing:retrospective
Last update:2020-05-12, 1399/02/23
Update count:0
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
minoo montazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4481 3915
Email address
minomah17@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
2019-10-12, 1398/07/20
Actual recruitment end date
2020-03-10, 1398/12/20
Trial completion date
2020-03-10, 1398/12/20
Scientific title
Comparison of topical and continuous infusion of Tranexamic Acid administration on bleeding in pediatric with non-cyanotic congenital heart disease
Public title
Comparison of topical administration and infusion of tranexamic acid on the rate of bleeding in children with non-cyanotic heart disease after open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 14 kg and over 6 kg
For the first time, they undergo cardiac surgery to correct the aforementioned non-cyanotic diseases with cardiac bypass.
Clamp aortic time between 60 to 90 minutes
CPB(cardio pulmonary bypass) time between 60 to 180 minute
Hemoglobin(HB) above 8 mg per deciliter before surgery
Minimum age 1 month and maximum age 9 years
Exclusion criteria:
hemoglobin below 8 mg per deciliter before surgery
Active non-revolutionary disease affecting postoperative recovery such as severe coagulation disorder, hemophilia and.
Age
From 1 month old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the census and random allocation, the samples were divided into two groups of 25 people. This randomization was performed using Random Allocation software 2.0, in which patients were assigned to one of two groups based on the number of entries in the study. This is done by a nurse outside the research team and the groups are identified as A and B. The unit of randomization is individual. Also, randomization in two groups is Balanced Block Randomization, ie the number of people in two groups is equal.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining informed consent from the patient's guardian (the study was performed on children), the study was one- blind side, in which only participants or patients were uninformed to the study groups, and the main staff and researchers and other colleagues who They were involved in this project, they were aware of the choice of group type, it was done.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committe of Isfahan university of medical sciences
Street address
No. 24, Baharestan 9th, Northen Janat Abad
City
Tehran
Province
Tehran
Postal code
1478777887
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.354
Health conditions studied
1
Description of health condition studied
Diseases of Atrial and Ventricular septum defect
ICD-10 code
I51.0
ICD-10 code description
Cardiac septal defect, acquired
Primary outcomes
1
Description
Bleeding rate in children with congenital non-cyanotic heart disease after open heart surgery
Timepoint
Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery
Method of measurement
To determine the amount of bleeding, hemoglobin is measured based on arterial sampling and sent to a laboratory to measure and record arterial blood gases, and the unit is geram per deciliter.
Secondary outcomes
1
Description
Time of intubation
Timepoint
Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery
Method of measurement
Hours and minute
2
Description
Intensive care unit stay
Timepoint
Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery
Method of measurement
Time and minute
3
Description
Mount of derenage
Timepoint
Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery
Method of measurement
According to cc
Intervention groups
1
Description
Intervention group:The first group of interventions includes patients undergoing continuous infusion of 50 mg per kg tranexamic acid from induction to sternum closure.
Category
Treatment - Drugs
2
Description
Intervention group:The second group of interventions are patients receiving topical administration of 50 mg per kg tranexamic acid, which has reached 20 ml with a normal saline solution. Before closing the sternum, it is poured into the pericardium and the patient's middle mediastan tubes are clamped for 20 minutes. (The nurse uses a sterile syringe to draw the drug into the syringe and then to a concentration of 20 ml).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital in Isfahan
Full name of responsible person
Hamid Bigdelian
Street address
No. 308, Northen Alley 1th, Alikhani Ave, Mehr Ave
City
Isfahan
Province
Isfehan
Postal code
1478777887
Phone
+98 31 3260 3145
Email
Hamidbigdelian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Montazeri
Street address
No. 24, Baharestan 9th, Notrthen Janat abad
City
Tehran
Province
Tehran
Postal code
1478777887
Phone
+98 21 4481 3915
Email
Minomah17@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Montazeri
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Perfusion
Street address
No.24 , Baharestan 9th, North Janat abad
City
Tehran
Province
Tehran
Postal code
1478777887
Phone
+98 21 4481 3915
Fax
Email
minomah17@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Bigdelian
Position
Head of Pediatric Cardiac Surgery and Perfusion Group
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 308,Notrth Alley 1th, Alikhani Ave, Mehr Ave
City
Isfahan
Province
Isfehan
Postal code
1478777887
Phone
+98 31 3260 3145
Email
hamidbigdelian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Montazeri
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Perfusion
Street address
No. 24, Baharestan 9th,Northen Janat Abad
City
Tehran
Province
Tehran
Postal code
1478777887
Phone
+98 21 4481 3915
Email
Minomah17@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
Some of the data related to the result is available.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
All of the searchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Executor or person in charge of the project
What processes are involved for a request to access data/document
Contact the executor or the person in charge of the project and up to one week after the contact (contact information is mentioned.)