| CTRI Number |
CTRI/2024/10/074877 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study using nebulized tranexamic acid to look for increased yield of biopsy specimens obtained during conventional endobronchial biopsies obtained |
|
Scientific Title of Study
|
Efficacy of nebulized tranexamic acid in improving yield
during endobronchial biopsies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineela Surapaneni |
| Designation |
Senior Resident |
| Affiliation |
Pandit B.D Sharma, PGIMS, Rohtak |
| Address |
Department of Pulmonary and Critical Care Medicine
PGIMS Rohtak
Department of Pulmonary and Critical Care Medicine, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9052968666 |
| Fax |
|
| Email |
vineela.surapneni228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhruva Chaudhry |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Pandit B.D Sharma, PGIMS, Rohtak |
| Address |
Department of Pulmonary Medicine, PGIMS-Rohtak
Department of Pulmonary Medicine, PGIMS-Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9991101616 |
| Fax |
|
| Email |
dhruvachaudhry@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vineela Surapaneni |
| Designation |
Senior Resident |
| Affiliation |
Pandit B.D Sharma, PGIMS, Rohtak |
| Address |
Department of Pulmonary Medicine, PGIMS-Rohtak
Department of Pulmonary Medicine, PGIMS-Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9052968666 |
| Fax |
|
| Email |
vineela.surapneni228@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pulmonary and critical care medicine, PGIMS - Rohtak, Haryana, India 124001 |
|
|
Primary Sponsor
|
| Name |
PGIMS ROHTAK |
| Address |
DEPARTMENT OF PCCM
PGIMS Rohatak
Haryana, India -124001 |
| 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 Vineela Surapaneni |
Pandit.B.D.Sharma Post graduate institute of medical sciences, Rohtak |
Room number 17, Department of Pulmonary and Critical Care Medicne,
PGIMS Rohtak, Haryana, 124001
India
Rohtak
HARYANA |
9052968666
vineela.surapaneni228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pandit.B.D.Sharma PGIMS/UHS,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NEBULIZATION WITH STERILE WATER |
Patients in control arm will be nebulized with 5 ml sterile water for 4 minutes |
| Intervention |
NEBULIZATION WITH TRANEXAMIC ACID BEFORE STARTING ENDOBRONCHIAL BIOPSIES |
intervention group subjects will be nebulised with tranexamic acid at a dose of 500mg(5ml)
of intravenous formulation of TXA. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged ≥18 years posted for fiberoptic bronchoscopy with a plan for obtaining
endobronchial biopsy. |
|
| ExclusionCriteria |
| Details |
1) Active and ongoing pulmonary bleeding (haemoptysis),
2) Known history of bleeding predisposition,
3) Decompensated liver disease,
4) Kidney disease (an estimated glomerular filtration rate of ≤30 ml/min),
5) Known allergy to tranexamic acid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of nebulized tranexamic acid in increasing the adequacy of endobronchial biopsy. |
Adequate sample will be
defined as biopsy sample sufficient for histopathology, immunohistochemistry, and molecular
analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy to control bleeding during endobronchial biopsy. |
Severity of bleeding: Mild: requiring continuous suctioning and bleeding stopped
spontaneously.
Moderate: requiring use of cold saline or epinephrine to control bleeding.
Severe: placement of bronchial blocker /balloon catheter/ applying fibrin sealant, fluid
resuscitation/ blood transfusion, admission to critical care unit or death. |
| To assess the procedure length. |
Length of the procedure from nebulization with study agent to end of the procedure.
Length of the procedure as assessed from introduction of scope to the end of the procedure. |
| To assess the number and size of biopsies obtained. |
Number of biopsies will be determined based upon successful passes taken and size will be
compared with the cup of the forceps, small- cup is bigger than tissue,Medium- tissue
fills the cup, large- tissue is largen than the cup |
| To assess the safety of nebulized tranexamic acid just prior to endobronchial biopsy. |
Incidence and frequency all adverse events and SAEs will be reported as per the CTCAE
Version 5.0. |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
14/10/2024 |
| 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="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Tranexamic acid is an antifibrinolytic agent that can be used to prevent the dissolution of fibrin clots. Recent studies have shown that using nebulized tranexamic acid would reduce hemoptysis in patients who presented to emergency. Bleeding is one of the well recognized complications of conventional endobronchial biopsies that could be sometimes life-threatening and would result in the reduced yield of the biopsy sample. The current study aims at studying the use of nebulized tranexamic acid in increasing the yield and controlling bleeding during endobronchial biopsy procedure |