Protocol summary
-
Study aim
-
Determination and comparison of mean intraoperative blood loss using three doses of tranexamic acid and control group
-
Design
-
A 3 phase clinical trial with three intervention groups and one control group as parallel groups, double-blind, simple randomized by coded card selection, and a sample size of 80
-
Settings and conduct
-
In this study, 80 children in Imam Hossein Pediatric Hospital in Isfahan candidate for cleft palate surgery are included in the study and divided into four groups. Anesthesia is induced on the day of surgery after initial data recording and then the four groups receive 5 mg/kg tranexamic acid (A), 7.5 mg/kg tranexamic acid (B) and 10 mg/kg tranexamic acid (C) and placebo (D), 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 four intervention groups receive 5 mg / kg tranexamic acid (A), 7.5 mg / kg tranexamic acid (B) and 10 mg / kg tranexamic acid (C) and placebo, normal saline (D), respectively by slow intravenous injection.
-
Main outcome variables
-
Blood volume lost
General information
-
Reason for update
-
Change intervention groups
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20171030037093N26
Registration date:
2019-12-16, 1398/09/25
Registration timing:
prospective
Last update:
2020-03-29, 1399/01/10
Update count:
1
-
Registration date
-
2019-12-16, 1398/09/25
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-03-30, 1399/01/11
-
Expected recruitment end date
-
2021-03-07, 1399/12/17
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Comparative study of the effect of three doses of tranexamic acid on reduction of bleeding during cleft palate surgery
-
Public title
-
Comparison of three 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:
80
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
blood loss
Primary outcomes
1
-
Description
-
The volume of blood lost
-
Timepoint
-
During operation
-
Method of measurement
-
Check list
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 7.5 mg / kg tranexamic acid by slow intravenous injection.
-
Category
-
Treatment - Drugs
3
-
Description
-
Third 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
4
-
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
-
Treatment - Drugs
1
-
Sponsor
-
-
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
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.
-
Comments
-