The effect of tranexamic acid injection on bleeding in liposuction
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 20 patients. The intervention and control group is a single patient and we will use the drug on one side and the placebo on the other side of this patient. The intervention and control sides of the patient (left or right sides) will be chosen randomly with the help of a random number table.
Settings and conduct
Patients are operated on in 15 Khordad and Shahid Modarres hospitals in Tehran. Patients are unaware of the side the drug is used. The surgeon is not informed of the side of that the drug is used. The surgeon marks the left and right specimens and hands them to the researcher and the researcher does not know which specimen is for the left or right side. The hemoglobin of the samples is measured and the bleeding volume is determined by the Klein formula and compared on both sides.
Participants/Inclusion and exclusion criteria
Entry condition: Patients who undergo liposuction in 15 Khordad or Shahid Modarres hospitals in Tehran
Conditions of non-entry:
- Diabetic patients
- BMI above 35
- Renal failure
- coagulation problems
-Patients taking aspirin or warfarin or another anticoagulant
-Patients with a history of DVT or CVA or thromboembolism
-Patients who have previously undergone liposuction or abdominoplasty
Intervention groups
In these patients, on one side of the body (for example, left or right side), tranexamic acid is used in the solution injected for liposuction, and the drug is not used on the opposite side, and then liposuction is performed and the amount of blood loss on both sides is compared.
Main outcome variables
The amount of volume injected
The amount of suctioned volume
Preoperative hemoglobin
The volume of suctioned blood on the control side
The volume of suctioned blood on the case side
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210124050124N1
Registration date:2021-01-27, 1399/11/08
Registration timing:prospective
Last update:2021-01-27, 1399/11/08
Update count:0
Registration date
2021-01-27, 1399/11/08
Registrant information
Name
Hatef Zirakzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2615 3126
Email address
hatef.zirak@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tranexamic acid in tumescent solution on blood loss in liposuction
Public title
The effect of Tranexamic acid on blood loss in liposuction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who refer to 15 Khordad or Shahid Modarres hospitals in Tehran for liposuction.
Exclusion criteria:
Diabetic patients
Body mass index more than 35
Renal insufficiency
Coagulation disorders
Aspirin or Warfarin use
Deep vein thrombosis or CVA or thromboemboli history
Previous liposuction or abdominoplasty
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, Transexamic acid is used on one side in the tumescent solution for liposuction and the drug is not used on the other side.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the intervention and control group is in fact a single patient and we will use the drug on one side and the placebo on the other side of this patient. The intervention and control sides of the patient (left or right sides) will be chosen randomly with the help of a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participating patients are unaware of which side of the drug is being used and are unconscious. Also, the surgeon who performs the liposuction is not informed on which side the medicine was used in the injected solution. The surgeon marks the left and right specimens and hands them to the researcher to measure the amount of bleeding, and the researcher does not know which specimen is for the left and which is for the right.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of medicine- Shahid Beheshti university of medical sciences
Volume of suctioned blood on case and control sides (ml)
Timepoint
The patient's hemoglobin is measured one day before surgery. After injecting tamiscent solution, we will wait for 15 minutes and then start suctioning. After suctioning, the canister containing the suctioned fluid is left in place for one hour and then a sample is sent to measure hemoglobin.
Method of measurement
The amount of injected and suctioned fluid is measured in milliliters with containers. The amount of suctioned fluid hemoglobin and the patient's blood hemoglobin are measured in grams per deciliter by a hematology analyzer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On one side of the patient's body, Tranexamic acid 500 mg per liter of normal saline is added to the tumescent solution used for suction. Wait 15 minutes then start the suction.
Category
Treatment - Surgery
2
Description
Control group: On the control side, tranexamic acid is not added to the tumescent solution of liposuction, and after 15 minutes, suctioning begins on this side.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
15 Khordad hospital - Tehran
Full name of responsible person
Hatef Zirakzadeh
Street address
Azodi street, Karimkhan Zand street, South Shahid Azodi Street
City
Tehran
Province
Tehran
Postal code
15987 64514
Phone
+98 21 8894 3434
Email
hatef.zirak@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Hatef Zirakzadeh
Street address
Yadegar Emam street, Intersection with Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
htfzrk@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Rezghi
Street address
Headquarters Building 2- Floor 5 - Shahid Beheshti University of Medical Sciences and Health Services -Yemen St. -- Shahid Abbas Arabi St. (Parvaneh) - Next to Taleghani Hospital -Shahid Chamran Highway -
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hatef Zirakzadeh
Position
Resident of plastic surgery
Latest degree
Subspecialist
Other areas of specialty/work
Plastic surgery
Street address
#504, Building C, 32nd st, Feizieh st, Nivaran st
City
Tehran
Province
Tehran
Postal code
1977151988
Phone
+98 21 2615 3126
Email
htfzrk@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hatef Zirakzadeh
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Plastic surgery
Street address
#504, Building C, 32nd st, Feizieh st, Niavaran st
City
Tehran
Province
Tehran
Postal code
1977151988
Phone
+98 21 2615 3126
Email
htfzrk@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hatef Zirakzadeh
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Plastic surgery
Street address
504 ,Apt C,No 38, 32nd st, Feizieh st, Niavaran st
City
Tehran
Province
Tehran
Postal code
1977151988
Phone
+98 21 2615 3126
Fax
Email
hatef.zirak@sbmu.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Patient data such as age, sex, body mass index, preoperative hemoglobin, injected and suctioned volume, and measured bleeding volume can be shared.
When the data will become available and for how long
The time for publishing this documents is three months after the publication of the article.
To whom data/document is available
The data will be available to researchers working in scientific and academic institutions.
Under which criteria data/document could be used
Documents will be available if you provide valid academic or official evidence of similar or other applied studies.
From where data/document is obtainable
To provide information, contact the responsible author of the article named Hatef Zirakzadeh by e-mail hatef.zirak@sbmu.ac.ir or htfzrk@yahoo.com.
What processes are involved for a request to access data/document
The request for documentation will be discussed by the responsible author with other researchers and will be submitted to the applicant within one month if approved.