| CTRI Number |
CTRI/2025/09/095175 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
In endonronchial biopsies there is high risk of bleeding for which prophylactic tranexamic acid is instilled to see for the reduction in bleeding |
|
Scientific Title of Study
|
Role of prophylactic tranexamic Acid instillation in reduction the severity of bleeding during Endobronchial biopsy: a double blind randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratyakcha Rai |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Delhi |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Ward
New Private Ward, 3rd floor, Pulmonary Medicine Ward
New Delhi
DELHI
110049
India |
| Phone |
7830653965 |
| Fax |
|
| Email |
raipratyakcha26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pratyakcha Rai |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Delhi |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Ward
New Private Ward, 3rd floor, Pulmonary Medicine Ward
New Delhi
DELHI
110049
India |
| Phone |
7830653965 |
| Fax |
|
| Email |
raipratyakcha26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratyakcha Rai |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Delhi |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Ward
New Private Ward, 3rd floor, Pulmonary Medicine Ward
New Delhi
DELHI
110049
India |
| Phone |
7830653965 |
| Fax |
|
| Email |
raipratyakcha26@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
All India Institute of Medical Sciences New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anant mohan |
All India Institute of Medical Sciences New Delhi |
New Private Ward 3rd floor, Pulmonary Medicine Ward, All India Institute of Medical Sciences New Delhi 110029
South
DELHI |
9810048204
anantmohan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Normal Saline 5 ml endobronchial as soon as the lesion is visible |
| Intervention |
Tranexamic Acid |
500mg(5 ml) of tranexamic acid instilled endobronchial as the lesion is visible |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with endobronchial lesion in form of growth, infiltration, nodularity as seen during bronchoscopy |
|
| ExclusionCriteria |
| Details |
Any contraindication for biopsy that is coagulopathy or hemodynamically unstable condition for bronchoscopy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine the difference in the proportion of patients with moderate to severe between the intervention and the control arm
|
During procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety End Points: The incidence of thromboembolic events, including myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism. |
1 month |
Difference in the proportion of patients with each grade of bleeding (1 to 4) as assessed by the bronchoscopist performing the procedure.
|
During procedure |
The difference in the duration of the procedure
|
During procedure |
| Premature interruption of procedure |
During procedure |
Bronchoscopist graded patient’s tolerance of the procedure using the VAS scale
|
During procedure |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/10/2025 |
| 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="2"
Months="6"
Days="1" |
|
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
|
Bleeding is a common occurence during endobronchial biopsy and Tranexamic Acid being an antifibrinolytic is demonstrated in this trial |