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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  
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 
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  
Status 
Not Applicable 
 
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. 

 
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