| CTRI Number |
CTRI/2025/10/096389 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see how well certain medicines control bleeding in patients with bone fractures. |
|
Scientific Title of Study
|
Randomised controlled trial on the role of Tranexamic acid in patients with open fractures |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjit Bansal |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of medical education and research |
| Address |
Department of Orthopaedic Surgery, PGIMER, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7610949488 |
| Fax |
|
| Email |
utkarshreddy1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arjit Bansal |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of medical education and research |
| Address |
Department of Orthopaedic Surgery, PGIMER, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7610949488 |
| Fax |
|
| Email |
Arjitbansal28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arjit Bansal |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of medical education and research |
| Address |
Department of Orthopaedic Surgery, PGIMER, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7610949488 |
| Fax |
|
| Email |
utkarshreddy1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH [PGIMER] |
|
|
Primary Sponsor
|
| Name |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH PGIMER |
| Address |
DEPARTMENT OF ORTHOPEDICS PGIMER, SECTOR 12, CHANDIGARH |
| 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 Arjit Bansal |
PGIMER [Postgraduate Institute Of Medical Education And Research] |
Department Of Orthopaedics [room no 15], Old Nehru Building, Postgraduate Institute Of Medical Education and Research [PGIMER], Chandigarh.
Chandigarh
CHANDIGARH |
7610949488
Arjitbansal28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
double dose INJ TRANEXAMIC ACID |
patients will be given injection tranexamic acid either single dose or double dose or a placebo based on randomisation |
| Comparator Agent |
Placebo |
patients will be given injection tranexamic acid either single dose or double dose or a placebo based on randomisation |
| Intervention |
Single dose INJ TRANEXAMIC ACID |
patients will be given injection tranexamic acid either single dose or double dose or a placebo based on randomisation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than or equal to 18 years
Gustilo Anderson Type I,II,III open fractures
Informed consent obtained
|
|
| ExclusionCriteria |
| Details |
Known allergy to Tranexamic Acid
History of thromboembolic disease DVT, PE, MI, stroke
On anticoagulants or antiplatelet therapy at presentation
Renal dysfunction (CrCl less than 30 mL per min)
Hepatic failure
Pregnancy or lactation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Estimated total blood loss until discharge: Includes intraoperative suction volume, gauze weighing, drain output (if used), and visible postoperative bleeding.
2. Haemoglobin and haematocrit changes: Measured at baseline, 24, 48, 72 hours and 7 days postoperatively.
3. Need for blood transfusion: Proportion of patients transfused and total number of units transfused. In cases requiring a second surgery, total units transfused till the second surgery.
4. Intraoperative blood loss: Documented by the anaesthesia and surgical team
|
At presentation
8 hours
Postoperative (24, 48,72 hours and 7 day)
Daily until discharge
At discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Platelet count at baseline & postoperatively (to assess coagulopathy)
2. Wound-related complications: infection, hematoma, wound necrosis, dehiscence
3. Incidence of thromboembolic events (clinically suspected DVT, PE, MI, stroke)
4. Length of hospital stay
5. Adverse drug reactions (allergic reactions, seizures, etc.)
|
1. baseline & post operative
2.postoperative period only
3.through out the stay, no specific time point
4.nil
5.after administering drug |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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)
|
01/12/2025 |
| 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 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
|
This protocol outlines a randomized controlled trial assessing the efficacy of a two-dose intravenous tranexamic acid regimen in adults with open fractures. The study aims to determine whether administering 1 gram of TXA at presentation and another after 8 hours reduces perioperative blood loss compared to single-dose TXA and placebo. It involves 250 participants divided equally into three groups. Primary outcomes include estimated blood loss and transfusion requirements, while secondary outcomes cover complications, thromboembolic events, hospital stay, and mortality. The trial ensures ethical conduct, informed consent, and double-blind randomization to maintain scientific validity and patient safety |