Determining and comparing the average volume of bleeding and the incidence of rebleeding on the side of the tonsil receiving tranexamic acid and on the side of the tonsil receiving placebo during surgery and recovery
Determining and comparing the average score of the surgeon's satisfaction on the side of the tonsil receiving transexamic acid and the side of the tonsil receiving placebo
Determining and comparing the average duration of surgery in the tonsillar side receiving tranexamic acid and the tonsil side receiving placebo
Design
Clinical trial with control group with single group, double-blind, randomized, phase 2 on 20 randomized patients using randomization software
Settings and conduct
Operating room of Al-Zahra and Kashani hospitals in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients aged 15 to 45 years who are candidates for tonsillectomy with functional status 1 and 2 according to the criteria of the American Society of Anesthesiologists (ASA) and informed consent to participate in the study.
Exclusion criteria : contraindication of tranexamic consumption for any reason including drug allergy, use of anticoagulants by the patient, hematological diseases (hemolytic disease, hemoglobinopathies, coagulopathy and thromboembolic events), uncontrolled systemic diseases, patient dissatisfaction and cauter is used to control bleeding during surgery.
Intervention groups
Tranxamic acid is injected randomly into the bed of the right or left tonsil.
Intraoperative bleeding for each side of the tonsils up to 24 hours after surgery. The surgeon's satisfaction is assessed.
In each patient, distilled water will be injected into the tonsils on the opposite side, which is considered as control.
Main outcome variables
Bleeding rate; Moderate arterial blood pressure; heart beat; Surgeon Satisfaction; Duration of Surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211028052900N2
Registration date:2022-05-01, 1401/02/11
Registration timing:registered_while_recruiting
Last update:2022-05-01, 1401/02/11
Update count:0
Registration date
2022-05-01, 1401/02/11
Registrant information
Name
Maryam Fatahinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 3176
Email address
rezamdmr70@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical tranexamic acid injection on bleeding during and after tonsillectomy in patients aged 15 to 45 years
Public title
The effect of topical tranexamic acid injection on bleeding during and after tonsillectomy in patients aged 15 to 45 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
15 to 45 years old
Functional class 1 and 2
Exclusion criteria:
contraindication of the use of tranexamic acid for any reason, including allergies to the drug
Anticoagulants consumption
Hematologic disorders
Uncontrolled systemic diseases
Use a catheter to control bleeding during surgery
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is a simple randomization that is done by statistical software. The list of patients under study is prepared in advance, which includes 20 people.
10 people are supposed to be injected on the right side and 10 people on the left side, and in each of them placebo will be injected in the opposite side.
Then, using random allocation software, 10 people are randomly placed in the right group and 10 people in the left group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main surgeon is blind to assigning the study group. The assistant surgeon injects tranexamic acid into a patient's tonsil bed and injects distilled water into the opposite side, and the primary surgeon is unaware of the injection of tranexamic acid acid. The patient will not be informed of the side where the tranexamic acid was injected.
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 Science
Street address
Isfahan , Hezarjarib ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746.
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
IR.MUI.MED.REC.1400.821
Health conditions studied
1
Description of health condition studied
TONSILECTOMY
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
amount of bleeding during tonsillectomy
Timepoint
24 hour after surgery
Method of measurement
The amount of blood collected in the suction and the change in weight of the soaked gas
Secondary outcomes
1
Description
Surgeon satisfaction
Timepoint
after surgery
Method of measurement
Scale one to ten
Intervention groups
1
Description
Intervention group: 10 minutes before surgery, 100 mg of tranexamic acid is injected randomly into the bed of the right or left tonsil. The amount of intraoperative bleeding is calculated for each side of the tonsils (based on the volume of blood inside the calibrated suction and the difference in weight of blood gases before and after use, which is considered the difference in weight equal to 1 cc of blood per gram. Recovery for each side of the tonsils is performed up to 24 hours after the operation by a nursing expert who was unaware of the type of intervention drug in the patient. The score is evaluated from 0 to 10. The lowest satisfaction score is zero and the highest satisfaction score is 10 (obtained for each side of the tonsils separately). The type of surgical technique performed for all patients is cold dissection and homeostasis by suture.
Category
Treatment - Drugs
2
Description
Control group: An equal volume of distilled water is injected into the opposite side of the tonsil and the amount of bleeding during the operation for each side of the tonsil (based on the volume of blood inside the calibrated suction and the difference in weight of blood gases before and after use. Blood is considered to be calculated, and also the occurrence of bleeding in the recovery for each side of the tonsils up to 24 hours after the operation is done by a nursing expert who was unaware of the type of intervention drug in the patient. It is deducted from the volume inside the suction device. The surgeon's satisfaction is evaluated based on a score from 0 to 10, which will have the lowest satisfaction score of zero and the highest satisfaction score of 10 (which is obtained for each side of the tonsils separately). Surgery is performed for all patients with cold dissection and homeostasis by suture.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
alzahra hospital
Full name of responsible person
Ali badrooj
Street address
sofe bolved
City
isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
dr mansour siavash dastjerdi
Street address
hezarjarib avenue
City
isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 3071
Email
research@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
ali badrooj
Position
medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezarjarib avenue
City
isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 2020
Email
abadrooj@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ali badrooj
Position
medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezarjarib avenue
City
isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 2020
Email
abadrooj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ali badrooj
Position
medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezarjarib avenue
City
isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 2020
Email
abadrooj@gmail.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
All data is potentially shareable after unidentifiable individuals.
When the data will become available and for how long
Start of access period 1 month after printing the results
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Statistical analysis and the use of anonymous and unidentifiable documents will be possible after obtaining permission from the study researchers, provided by email.
From where data/document is obtainable
It is possible to access the studies by email or by contacting the responsible researcher, Ali Badrouj.
abadrooj@gmail.com
00989140814990
What processes are involved for a request to access data/document
After submitting the request to the responsible researcher, he / she will consult with other researchers and after obtaining the opinions of other researchers, the applicant will be answered within 1 week.