Determining the effect of topical tranexamic acid on the amount of bleeding in the wounds of burn patients after removing the skin in order to reduce the need for blood transfusion and reduce bleeding complications
Design
Patients will be randomly assigned to two groups in a ratio of one to one (40 people in each group). The first group or the intervention group will receive local tezangsamic acid and the second group will be the control group in which only gauze impregnated with epinephrine is placed on the debrided wound during surgery.
Settings and conduct
This clinical trial in the field of burn patients requires skin debridement, which was carried out during the year 1403 in Shahid Madani Hospital, Karaj. The first group or the same intervention group during burn debridement received one vial of topical tranexamic acid (1 gram vial containing 500 cc of serum dissolved normal saline) is placed on the debridement wound. The second group, the control, only gauze impregnated with epinephrine is placed on the debridement site.
This study is double-blind, so that the outcome assessor and the subject will be unaware of the status of assigning people to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People aged 15 to 55 with deep thermal burns with dimensions greater than 20% of the total body surface
Exclusion criteria:
Chemical or electrical burns
3rd degree burns
Intervention groups
Patients will be randomly assigned to two groups in a ratio of one to one (40 people in each group). The first group or the intervention group will receive topical tezangsamic acid and the second group will be the control group
Main outcome variables
Hemoglobin, hematocrit, amount of cell pack received, length of stay and possible side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240228061125N1
Registration date:2024-03-16, 1402/12/26
Registration timing:prospective
Last update:2024-03-16, 1402/12/26
Update count:0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Tina Rahimzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3442 7001
Email address
tinarahimzadeh1390@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical Tranexamic Acid on the Bleeding Rate of the Burn Patient’s Wounds after Debridement،A Randomized Clinical Trial
Public title
Investigating the effect of topical tranexamic acid on burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients between 15-55 years old over than 20 percent surface of body
need skin debridement
Exclusion criteria:
dont need icu care
not to be third grade burn
dont have chemical or electrical burn
dont have blunt abdominal trauma or head trauma
dont have bleeding disorders
dont have thrombotic disorders or hypercoagulopathy
dont be post partum or pregnant
Hypersensitivity to tranexamic acid
Systolic blood pressure higher than 200 mmHg
Disruption of coagulation factors
Have disturbances in kidney function tests
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the block randomization method will be used, so that at first, blocks of four will be prepared in the Excel software as (AABB) (BBAA) (ABBA) (BAAB) (ABAB) (BABA). A will be the intervention group and B will be the control group. Then one of the blocks will be randomly selected and based on the sequence of letters in the selected block, the eligible people will be assigned to treatment groups. This random process of selecting blocks and assigning people to treatment groups will continue until the desired sample size is reached. The preparation of random allocation sequences of two intervention groups and placing them in closed (sealed) envelopes and numbering with a 5-digit serial number will be done by a third person who is not involved in the design of the study
All envelopes have a 5-digit serial number, which will be opened after recording background information, and the sample will be divided into two intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind, so that the outcome evaluator and the subject will be unaware of the status of assigning people to the study groups. For the study subjects, before random allocation, it will be explained how the work process is, and they may receive one of the two treatments randomly, and the treatment to be used will not be known to the person in advance; in such a way that it will not be possible for the patient to distinguish them from each other. Therefore, the patient will be unaware of which group he is in. Also, the outcome evaluator will not know about the status of assigning people to the study groups.Yes, two groups need to be randomized at the participant level
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
madani hospital of karaj
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2024-01-30, 1402/11/10
Ethics committee reference number
IR.ABZUMS.REC.1402.303
Health conditions studied
1
Description of health condition studied
Burn wound
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin level
Timepoint
Complete blood count test before operation and 24 hours after operation
Method of measurement
Complete blood count test through the patient's blood sample
2
Description
Hematocrit level
Timepoint
Complete blood count test before operation and 24 hours after operation
Method of measurement
Complete blood count test through the patient's blood sample
Secondary outcomes
1
Description
Occurrence of possible side effects
Timepoint
From the time the patient arrives to the time of discharge from the hospital
Method of measurement
Investigating the presence of side effects during hospitalization
2
Description
Duration of hospital stay
Timepoint
The time of arrival to the departure of the patient from the hospital
Method of measurement
Number of days of hospitalization
3
Description
The number of Pack cell received
Timepoint
After surgery
Method of measurement
The number of cell packs
Intervention groups
1
Description
Intervention group: . For the patients in the intervention group, the gauze dressing will be soaked in 500 mg diluted tranexamic acid plus 1 mg norepinephrine diluted in 500 ml 0.9% saline and placed on the bleeding area for 10 minutes after removing the skin.The pharmaceutical company of this drug can include Aburihan Pharmaceutical Company or Caspian Tamin Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: For patients in the control group, only gauze soaked in 1 mg of norepinephrine diluted in 500 ml of 0.9% saline will be placed on the wound for 10 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital of Karaj
Full name of responsible person
Tina Rahimzadeh
Street address
Madani sq.Madani hospital
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3442 7001
Email
ali.khes@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
saman sheikhi
Street address
Alborz university of medical
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
ali.khes@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
1
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
Karaj University of Medical Sciences
Full name of responsible person
Ali Esmaielzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Madani sq.Madani hospital
City
Karaj
Province
Alborz
Postal code
3819693345
Phone
+98 26 3419 7000
Email
Tinarahimzadeh1390@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Tina Rahimzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Karaj.madani sq.Madani hospital
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
Tinarahimzadeh1390@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Tina Rahimzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Madani sq.Madani hospital
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
tinarahimzadeh1390@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available