CTRI Number |
CTRI/2023/05/052223 [Registered on: 02/05/2023] Trial Registered Prospectively |
Last Modified On: |
01/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Preventive |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Prevention of bleeding after bronchoscopic biopsy with the use of prophylactic local tranexemic acid |
Scientific Title of Study
|
“Efficacy of prophylactic topical instillation of tranexamic acid versus cold saline for prevention of iatrogenic bleeding after flexible bronchoscopic biopsy: a double blind randomised control trial†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Amarendra Kumar Shukla |
Designation |
DM Resident |
Affiliation |
Pulmonary medicine department AIIMS Jodhpur |
Address |
Pulmonary Medicine Department, OPD building, ground floor B block, Room no 32
Jodhpur RAJASTHAN 342005 India |
Phone |
7307632248 |
Fax |
|
Email |
shuklaamarendrakumar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Nishant Kumar Chauhan |
Designation |
Additional Professor |
Affiliation |
Pulmonary medicine department AIIMS Jodhpur |
Address |
Room no 3025, 3RD FLOOR, Medical College Building, Pulmonary Medicine Department, AIIMS jodhpur
Jodhpur RAJASTHAN 342005 India |
Phone |
7307632248 |
Fax |
|
Email |
nishant97@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Amarendra Kumar Shukla |
Designation |
DM Resident |
Affiliation |
Pulmonary medicine department AIIMS Jodhpur |
Address |
Pulmonary Medicine Department, OPD building, Ground floor B block, Room no 32
Jodhpur RAJASTHAN 342005 India |
Phone |
7307632248 |
Fax |
|
Email |
shuklaamarendrakumar@gmail.com |
|
Source of Monetary or Material Support
|
No fund will be required for this study, material support will be obtained from Pulmonary medicine department of AIIMS Jodhpur, Rajasthan |
|
Primary Sponsor
|
Name |
Pulmonary Medicine Department of AIIMS Jodhpur |
Address |
Pulmonary Medicine Department, OPD building B block, Room no 32 AIIMS Jodhpur, Rajasthan |
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 |
AMARENDRA KUMAR SHUKLA |
Pulmonary medicine department, AIIMS jodhpur |
Pulmonary Medicine Department, OPD building, Ground floor, B block, Room no 32 RAJASTHAN 342005 Jodhpur RAJASTHAN |
7307632248
shuklaamarendrakumar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS Jodhpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J980||Diseases of bronchus, not elsewhere classified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Tranexamic acid |
Dose- 500 mg TXA (500 mg/5 mL given in 5 ml of saline before bronchoscopic endobronchial and transbronchial biopsy.
Route- Topical through working channel of bronchoscope.
Frequency- one time during procedure
Duration- 2 minutes before procedure
|
Comparator Agent |
cold saline |
Dose- cold saline (4°C, 10 ml of 0.9% NaCl) would be instilled through working chanel of bronchoscope.
Route- Topical
frequency- single
Duration- 2 minutes before bronchoscopic biopsy |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
1. Age > 18 years
2. All patients requiring EBB or TBLB and fulfilling the fitness to undergo flexible bronchoscopy.
3. Patients providing prior written informed consent
|
|
ExclusionCriteria |
Details |
1. Coagulopathy: INR >1.5
2. Thrombocytopenia: platelets count < 50000
3. Anaemia: haemoglobin < 7gm/dl
4. Ongoing treatment with direct oral anticoagulant agents (DOAC), low molecular weight heparin (LMWH) or dual antiplatelet therapy (DAPT)
5. Patients with unstable or recent coronary heart disease or cerebrovascular disease
6. Decompensated liver disease, end stage kidney disease
7. Uncontrolled arrhythmia.
8. Hemodynamic instability and cardiovascular decompensation: patients with hypotension (MAP<65mm of hg)
9. Severe hypoxemia prior to bronchoscopy start (PaO2<60mmog hg and Spo2 <90% with Fio2 of 60% or higher)
10. Refusal to consent
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To compare the efficacy of prophylactic topical instillation of TXA with cold saline for prevention or reduction of bleeding after endobronchial or transbronchial forceps biopsy during flexible bronchoscopy. |
6 months, 12 months, 18 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. The number of biopsies obtained
2. Need of additional measures (cold saline, ADR, Balloon tamponade) to achieve haemostasis in case of uncontrolled bleeding.
3. Assess the adverse effect of TXA.
|
6 months, 12 months, 18 months |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
08/05/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
All
patients satisfying the inclusion criteria during the study period will be
enrolled in the study after obtaining written informed consent. A routine clinical
examination will be done and all the baseline characteristics will be recorded.
Blood investigations like CBC, LFT, and KFT,
baseline ECG will be done along with coagulation parameters like PT/PTT/INR and
viral markers for HIV, Hep-B and Hep-C. Data will be collected according to a predesigned
proforma. Flexible bronchoscopy will be
performed in the bronchoscopy suite by two experienced bronchoscopists, one
will be the lead bronchoscopist and other will be assisting bronchoscopist. It
will be performed via either the oropharyngeal or nasopharyngeal route under
conscious sedation and local anaesthesia. Patient will be sedated with
intravenous injection of midazolam and fentanyl. Pharyngeal anaesthesia with
10% lidocaine spray will be applied before bronchoscopy. 2% lidocaine solution
will be instilled through the bronchoscope using spray-as-you go technique to
the trachea and main airways for local anaesthesia. Blood
pressure, heart rate, SPO2, electrocardiogram, and consciousness level will be
continuously monitored during the procedure. Bronchoscopy shall be performed using
Olympus (BF 1TH 190 or BF 1T150) bronchoscope. Through the working channel of
the bronchoscope, 500 mg TXA (500 mg/5 mL given in 5 ml of saline, or cold
saline (4°C, 10 ml of 0.9% NaCl) would be instilled as per the randomization sequence
in the target lobar bronchus or endobronchial lesion. After 2–3 min, forceps
biopsy specimens will be obtained with the aim of a minimum of four biopsies. We
will use dedicated biopsy forceps for EBB and TBLB. Bleeding severity shall be
graded by the assisting bronchoscopist, who will be blinded for prophylactic agent.
Assisting bronchoscopist will be asked to come inside the bronchoscopy suite only
after 2-3 minutes of instillation of prophylactic agent. Suctioning will be
performed using a wall-mounted suction system. Need for bleeding control
measures (i.e. cold saline, topical adrenaline or wedge tamponade) will be
recorded for all procedures. Patient will be observed in a recovery area for at
least 2 hours after bronchoscopy, routine chest X-ray will be performed before
discharge, in cases of transbronchial lung biopsy or as per clinical indication.
Follow-up telephone calls and medical record reviews will be performed at 1 month
to detect any adverse events such as myocardial infarction, stroke, seizures, deep
vein thrombosis, or pulmonary embolism.
The
bleeding severity will be graded by the bronchoscopist using visual analog
scale (VAS; 1 - very mild, 10 – very severe). and BTS classification of
bleeding severity.
|