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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  
Shilpa Medicare Limited. 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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