Investigating the effect of topical tranexamic acid on the amount of bleeding during and after tonsillectomy surgery
Design
The clinical trial will have a control and intervention group, in parallel and double-blind trial, randomized by a simple randomization method using a closed envelope and a phase 2-3 clinical trial study on 60 patients.
Settings and conduct
The study will be conducted on 60 patients referred to Ghaim Hospital (AJ) in Mashhad who are candidates for tonsillectomy surgery, which are placed in the intervention and control groups in a parallel double-blind trial (participant, evaluators). In the intervention group, tranexamic acid will be injected intravenously, and in the control group, normal saline will be injected during surgery. The effect of intervention on the amount of bleeding in two groups will be compared.
Participants/Inclusion and exclusion criteria
The main condition for entering the study is the informed consent of the patient and the need to perform tonsillectomy surgery, and the absence of bleeding diseases, the presence of non-relative hypertrophy of the tonsils, and the absence of a history of sensitivity to tranexamic acid.
Intervention groups
In the intervention group, tranexamic acid (5 ml vial of tranexamic acid 100mg/ml) is injected locally into the tonsils on both sides of the anterior pillar during surgery. In the control group, a 5 ml vial of normal saline is injected locally into the patient's tonsils during surgery.
Main outcome variables
The amount of bleeding based on suctioned blood volume and gas pack
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210923052559N3
Registration date:2023-11-22, 1402/09/01
Registration timing:prospective
Last update:2023-11-22, 1402/09/01
Update count:0
Registration date
2023-11-22, 1402/09/01
Registrant information
Name
Farzaneh Iravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3723 1750
Email address
farzaneh.baroon@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-10, 1402/09/19
Expected recruitment end date
2024-03-09, 1402/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of topical tranexamic acid in level of bleeding during and after tonsillectomy surgery
Public title
Investigating the effect of tranexamic acid on tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient
Patients who are candidates for tonsillectomy surgery
Exclusion criteria:
Suffering from bleeding diseases
The presence of tonsillar hypertrophy
History of sensitivity to tranexamic acid
Abnormal bleeding from the adenoid during surgery
Taking drugs that may increase bleeding, such as aspirin
Age
From 5 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done by www.randomization.com website . Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study subjects and those who evaluate the outcome in the participants will be unaware of the intervention and control groups due to the fact that the placebo is used in the study in parallel with the drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-09-18, 1402/06/27
Ethics committee reference number
IR.MUMS.IRH.REC.1402.127
Health conditions studied
1
Description of health condition studied
Haemorrhage due to tonsillectomy surgery
ICD-10 code
Y60
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care
Primary outcomes
1
Description
The amount of bleeding
Timepoint
During surgery, 24 hours and one week after surgery
Method of measurement
The amount of bleeding is calculated based on the amount of suctioned blood and gas pack. The blood volume of each small gas of 10 x 10 cm size is considered to be about 12 cc, the blood volume in the suction tube is also evaluated.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, immediately at the beginning of the tonsillectomy procedure, trangesamic acid (a 5 ml vial of trangesmic acid 100 mg/ml) will be injected at the dose of 10 mg/kg to the tonsils of the patients. In each patient, the injection in the anterior pillar will be done once in the upper, middle and lower part.
Category
Treatment - Surgery
2
Description
Control group: In the control group, normal saline (in the same vials with tranexamic acid with 5 ml volume ) will be injected into the tonsils of the patients at the beginning of the tonsillectomy procedure. The injection in the anterior pillar will be done once in the upper, middle and lower part.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Imaneh Roshanzamir
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
roshanzamiri@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour Mobarhan
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Imaneh Roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
roshanzamiri@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Imaneh Roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
roshanzamiri@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Imaneh Roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
roshanzamiri@mums.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