Determination and comparison of mean intraoperative blood loss using two doses of tranexamic acid and control group
Design
A 3 phase clinical trial with two intervention groups and one control group as parallel groups, double-blind, simple randomized by coded card selection, and a sample size of 75
Settings and conduct
In this study, 63 children in Imam Hossein Pediatric Hospital in Isfahan candidate for cleft palate surgery are included in the study and divided into three groups. Anesthesia is induced on the day of surgery after initial data recording and then the three groups receive 5 mg/kg tranexamic acid (A) and 10 mg/kg tranexamic acid (B) and placebo (C), respectively. Bleeding during surgery is accurately measured based on the amount of blood in the suction and the count of bloody gases (to calculate per gas 4 x 4 cm, 15 cc, and for larger, 30 x 30 cm, bloody gases, 50 ml of blood is considered). Surgeons' satisfaction about field of surgery is also recorded based on the Boesaart scoring system for field bleeding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age less than 3 years
2- Class ASA I, II
3. No history of systemic disease
4- Consent to participate in this study (by parents)
Exclusion criteria:
1. The operation lasts more than 3 hours
2. Incidence of surgical and anesthesia complications
3. Hypersensitivity or other contraindications to tranexamic acid use
4. History of coagulation disorders (such as hemophilia)
5. Having previous surgery in the same area
6.Children without parental consent or withholding cooperation in the project
Intervention groups
The three intervention groups receive 5 mg / kg tranexamic acid (A) and 10 mg / kg tranexamic acid (B) and placebo, normal saline (C), respectively by slow intravenous injection.
Main outcome variables
Blood volume lost during cleft palate surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N26
Registration date:2019-12-16, 1398/09/25
Registration timing:registered_while_recruiting
Last update:2019-12-16, 1398/09/25
Update count:1
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-27, 1398/09/06
Expected recruitment end date
2021-01-25, 1399/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of two doses of tranexamic acid on reduction of bleeding during cleft palate surgery
Public title
Comparison of two doses of tranexamic acid on reduction of cleft palate surgery bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 3 years
Has ASA class I, II
No history of systemic disease
Consent to participate in this study (by parents)
Exclusion criteria:
Prolonged surgery longer than 3 hours
Incidence of surgical and anesthesia complications
Hypersensitivity or other contraindications to tranexamic acid use
A history of coagulation disorders (such as hemophilia)
Prior surgery in the same area
Children without parental consent or withholding of participation in the project
Age
To 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, simple randomization with individual unit is used, so that patients randomly select one of the cards containing the codes A or B or C so they enter one of the three treatment groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the treatments are different doses, the drugs will be prepared at the desired doses and will be indicated in packages with codes A, B and C; To ensure that the registrant of patients information and the surgeon does not have any awareness of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUI.MED.REC.1398.057
Health conditions studied
1
Description of health condition studied
Intraoperative bleeding in cleft palate surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The volume of blood lost
Timepoint
During operation
Method of measurement
Check list
2
Description
Surgeon's satisfaction
Timepoint
During operation
Method of measurement
Boesaart scoring system
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: One group of patients undergoing cleft palate surgery after induction of anesthesia received 5 mg / kg tranexamic acid by slow intravenous injection.
Category
Treatment - Drugs
2
Description
Second intervention group: One group of patients undergoing cleft palate surgery after induction of anesthesia received 10 mg / kg tranexamic acid by slow intravenous injection.
Category
Treatment - Drugs
3
Description
Control group: One group of patients undergoing cleft palate surgery after induction of anesthesia received normal saline as placebo by slow intravenous injection.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
In Imam Hossein Pediatric Hospital, Isfahan
Full name of responsible person
Amir Shafa
Street address
Imam Hossein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
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
Amir Shafa
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not 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 about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Imam Hussein Hospital
What processes are involved for a request to access data/document
After the investigation of the researcher request and presentation of required documents will be accessible.