Determination of the effect of intravenous tranexamic acid in reducing the volume of bleeding during debridement of acute burn wounds
Design
This study is a randomized, double-blind clinical trial that has drug intervention groups (tranexamic acid) and placebo (normal saline) on 40 patients. Randomization will be done using a table of random numbers.
Settings and conduct
Patients referred to Shahid Motahari Burn Accident Hospital in Tehran are included in the study. This study is double-blind, the surgeon and the researcher are unaware of the groups. The patients will be randomly assigned to one of the drug and placebo groups. In the drug group, 10 mg/kg tranexamic acid will be injected and in the placebo group, 10 ml of normal saline will be injected about 10 minutes before the surgery. By measuring hemoglobin before and after the operation, we estimate the volume of bleeding during the operation and then compare between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 15 and 55 years, Patients with thermal burns less than 30% of the body surface who are candidates for surgical debridement of acute burn wounds.
Exclusion criteria: Patients with chemical burns, Patients with a history or tendency to thrombosis, Patients with a history of sensitivity to tranexamic acid, Patients with subarachnoid hemorrhage, Patients with renal dysfunction, Pregnancy, Breastfeeding.
Intervention groups
The group of tranexamic acid that receives medicine. The placebo group that receives normal saline.
Main outcome variables
The volume of blood lost during surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240301061135N1
Registration date:2024-03-12, 1402/12/22
Registration timing:prospective
Last update:2024-03-12, 1402/12/22
Update count:0
Registration date
2024-03-12, 1402/12/22
Registrant information
Name
Majid Javadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
drmajidjavadips@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous tranexamic acid in reducing the volume of bleeding after debridement of acute burn wounds
Public title
Investigating the effect of intravenous tranexamic acid in reducing the bleeding volume of acute burn surgical debridement
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with thermal burns less than 30% of the body surface who are candidates for surgical debridement of acute burn wounds.
Exclusion criteria:
Patients with chemical burns
Patients with history or susceptibility to thrombosis
Patients with a history of sensitivity to tranexamic acid
Patients with subarachnoid hemorrhage
Patients with renal dysfunction
Pregnancy
Breastfeeding
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are placed in one of the two groups of tranexamic acid injection or placebo injection using the random number table method, and accordingly receive tranexamic acid injection or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical caregiver and the anesthesiologist who injects the drug to the patient through the operating room nurse are aware of the study group receiving the drug or placebo; the surgeon, the principal investigator, the data collector and the data analyst are unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.IUMS.FMD.REC.1402.511
Health conditions studied
1
Description of health condition studied
The effect of intravenous tranexamic acid in reducing bleeding volume after surgical debridement of acute burn wounds
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The volume of blood lost during surgical debridement of burn wounds