| CTRI Number |
CTRI/2025/06/088232 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Tranexamic acid spray to quickly stop Bleeding in acute Trauma patients |
|
Scientific Title of Study
|
Efficacy of Tranexamic acid spray on reduction of time taken for a complete cessation of Bleeding in acute Trauma patients |
| 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 Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. 117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. South DELHI 110029 India |
| Phone |
08518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Subhashinii BSD |
| Designation |
Scientist |
| Affiliation |
AIIMS |
| Address |
117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. 117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. South DELHI 110029 India |
| Phone |
9625109486 |
| Fax |
|
| Email |
Kotarkonda@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
Dr Tej Prakash Sinha |
| Address |
117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. 117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. South DELHI 110029 India |
| Phone |
08518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shilpa Medicare Ltd. |
| Address |
Shilpa Medicare Limited
#12-6-214/A1,
Hyderabad Road,
Raichur – 584 135,
Karnataka, India.
Telephone: 08532 - 238704
Fax: 08532 - 238876
Email: info@vbshilpa.com |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Tej Prakash Sinha |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029.
117, First Floor,
Emergency Medicine,
JPN Apex Trauma Center,
AIIMS, New Delhi-110029. South DELHI |
08518881749
drsinha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T148||Other injury of unspecified body region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo spray (0.9 % w/v nacl) |
Placebo spray before bleeding as compared to tranexamic acid spray |
| Intervention |
Tranexamic Acid spray |
Tranexamic Acid before bleeding as compared to placebo spray |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adult more than 18 years acute trauma patients with isolated extremity wounds with active bleeding
Time since injury - less than 6 hours.
|
|
| ExclusionCriteria |
| Details |
Paediatric trauma patient age less than 18 yrs
Patients with known Blood Coagulopathy
Patients on anti-platelet and anti-fibrinolytics
Patients suffering with Co-morbidities and pregnant women
Patients with a history of hypersensitivity to tranexamic acid and any of the ingredients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Tranexamic acid (TXA) spray 10% w/v with placebo (Placebo spray) on acute injury patients admitted to the ED. |
Proportion achieving haemostasis within 5, 10, 15 minutes compared to placebo |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate the safety of the Tranexamic acid (TXA)spray 10% w/v with placebo (Placebo spray) on acute injury patients admitted to the ED. |
1h, 12 h, & 24h post-spray application |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Adequate
haemostasis after trauma and during surgical operation is a big challenge in
modern medicine. About the 40% traumatic and more than 90% of combat deaths
took place in pre-hospital settings. And about the 50% from these deaths have
been reported due to massive blood loss (1,2). The US FDA first approved
intravenous Tranexamic acid (TXA) in 1986 for short-term use as hemostatic
agent. In 2009, FDA approved the Tranexamic acid (TXA) oral form (Tablets) for
the treatment of menorrhagia. Tranexamic acid -4-(aminomethyl)
cyclohexane-1-carboxylic acid- is a synthetic amino acid lysine derivative that
competitively blocks the lysine binding sites on plasminogen (3,4).
Intravenous
Tranexamic acid is commonly used in severely bleeding patients and number
clinical trials were conducted. In 2010, CRASH-2 trial was a multi-center
randomized, double-blinded, controlled trial where patients either received
Tranexamic acid or placebo in adult trauma patients with significant
hemorrhage, tranexamic acid reduced all-cause mortality at 4 weeks and the
death rate due to bleeding in trauma patients (5,6). The MATTERs trial followed
this in 2011 revealed TXA decreased overall mortality, notably those requiring
massive transfusion protocols (7). The off-label intravenous uses of Tranexamic
acid are seen in surgical operations to reduce blood loss. Surgical operations
like total knee arthroplasty (8), orthognathic surgery (9), cardiac surgery
(10) spinal surgeries, and transurethral retrograde prostatectomy (TURP,11).
Based on
results of clinical studies, oral Tranexamic acid was also used to reduce blood
loss in post-procedural after cervical conization (12) hereditary angioedema (13),
transurethral retrograde prostatectomy (TURP) and tooth extractions in patients
on oral anticoagulants (14). The research studies observed that Tranexamic acid
is effective in reducing blood loss and transfusion without significant risks
for increased mortality, stroke, myocardial infarction, or renal failure (15,16,17).
In this
context, In the emergency and trauma setting, as bleeding control is an
important part, we are planning to investigate the use of tranexamic acid
spray. |