| CTRI Number |
CTRI/2026/02/104579 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intravenous trenexamic acid in burns surgery- an interventional study |
|
Scientific Title of Study
|
A study to assess the efficacy of intravenous tranexamic acid prior to burns surgery in a tertiary care centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PEDDI MANJUNATH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, FORT, KRISHNA RAJENDRA ROAD, KALASIPALYA, BENGALURU, KARNATAKA
Bangalore
KARNATAKA
560002
India |
| Phone |
9986084045 |
| Fax |
|
| Email |
peddim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRASHALI CHAUHAN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, FORT, KRISHNA RAJENDRA ROAD, KALASIPALYA, BENGALURU, KARNATAKA
Bangalore
KARNATAKA
560002
India |
| Phone |
8287379454 |
| Fax |
|
| Email |
prashali.chauhan6795@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRASHALI CHAUHAN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, FORT, KRISHNA RAJENDRA ROAD, KALASIPALYA, BENGALURU, KARNATAKA
Bangalore
KARNATAKA
560002
India |
| Phone |
8287379454 |
| Fax |
|
| Email |
prashali.chauhan6795@gmail.com |
|
|
Source of Monetary or Material Support
|
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 |
|
|
Primary Sponsor
|
| Name |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRASHALI CHAUHAN |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Department of plastic surgery, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
8287379454
prashali.chauhan6795@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T312||Burns involving 20-29% of body surface, (2) ICD-10 Condition: T312||Burns involving 20-29% of body surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
isotonic saline |
isotonic saline 10ml given 10 mins prior to surgery only once |
| Intervention |
trenexamic acid |
iv tranexamic acid 15mg/kg 10 mins prior to surgery given only once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All males and females aged 18-60 yrs
All patients with less than 30% deep dermal (2nd degree and above) burns
Patient willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy
Pregnancy
Patients with chronic kidney disease
Patients with allergy to tranexamic acid
Acute venous or arterial thrombosis within 3 months of inclusion in the study
Seizure disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood loss in ml
Amount of blood transfusion required
Pre and post op hemoglobin and hematocrit
|
blood loss assessed intra operatively
amount of blood transfusion required on post op day 1
pre and post op hemoglobin and hematocrit on post op day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of graft uptake |
post op day5 7 and 14 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Blood loss during excisional surgery in burn patients remains a challenge and has been identified as an independent predictor of mortality Limited interventions are available to decrease blood loss during burns surgery like use of topical adrenaline, topical tranexamic acid & tourniquet Despite the use of these techniques, blood loss during burn surgery is substantial This leads to allogenic blood transfusions with all associated risks and costs Tranexamic acid is a synthetic lysine analogue that competitively inhibits the activation of plasminogen, thereby inhibiting the degradation of fibrin Tranexamic acid has a proven efficacy in reducing blood loss in different patient categories The study aims to identify if blood loss is decreased by use of intravenous tranexamic acid prior to burns surgery as blood loss is an important indicator of morbidity & mortality post burn surgery |