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CTRI Number  CTRI/2024/04/065635 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Management of Blood in Cough 
Scientific Title of Study   Bronchial Artery Embolization in the Management of Hemoptysis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudhanshu Tonpe 
Designation  Senior Resident 
Affiliation  Datta Meghe Institute of Higher Education Research 
Address  Department of Interventional Radiology Sawangi Meghe Wardha Maharashtra 442004
Department of Interventional Radiology Sawangi Meghe Wardha Maharashtra 442004
Wardha
MAHARASHTRA
440001
India 
Phone  09420856987  
Fax    
Email  sudhanshutonpe@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pankaj Banode 
Designation  Head of department 
Affiliation  Department of Interventional Radiology Sawangi Meghe Wardha Maharashtra 442004 
Address  Department of Interventional Radiology Sawangi Meghe Wardha Maharashtra 442004

Wardha
MAHARASHTRA
440001
India 
Phone  8885481235  
Fax    
Email  drpjbanode@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pankaj Banode 
Designation  Head of department 
Affiliation  Department of Interventional Radiology Sawangi Meghe Wardha Maharashtra 442004 
Address  Department of Interventional Radiology Sawangi Meghe Wardha Maharashtra 442004

Wardha
MAHARASHTRA
440001
India 
Phone  8885481235  
Fax    
Email  drpjbanode@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra India 442107 
 
Primary Sponsor  
Name  DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  Sawangi Wardha Maharashtra India 442107  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudhanshu Tonpe  Department of Interventional Radiology  Datta Meghe Institute of Medical Sciences Jawaharlal Nehru Medical College Sawangi Wardha Maharashtra India 442107
Wardha
MAHARASHTRA 		 9420856987

sudhanshutonpe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education & Research (DMIHER) INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract, (2) ICD-10 Condition: J42||Unspecified chronic bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bronchial artery embolization  Embolization of the bronchial artery by PVA particles in cases of hemoptysis Dose- 2-5 cc Frequency- 1-2 minutes during the procedure Route of administration- Intra arterial Total duration 10 Minutes  
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. The potential candidate for BAE is a patient meeting any of the following criteria:
2. Hemoptysis >200ml /h or 600 ml /24 hrs
3. Hypovolemia due to acute Hemoptysis with systolic BP 90 mm hg.
4. Respiratory failure due to acute Hemoptysis requiring endotracheal intubation and mechanical
ventilation. 
 
ExclusionCriteria 
Details  1. Patients not giving consent for the procedure.
2. Patients having deranged coagulation profile.
3. Patients declared unfit on pre-anaesthetic checkups due to co-morbidities
4. Pregnant patients.
5. Allergic to contrast media
6. Deranged KFT 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement of symptoms  1 month 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 2/ Phase 3 
Date of First Enrollment (India)   23/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   STUDY DESIGN:Prospective observational study. TIME FRAME / DURATION: 2YEARS METHODOLOGY: The study will be conducted after approval from the institutional ethical committee in our institution, a tertiary care hospital, for two years. Patients presenting with massive Hemoptysis referred to our department will be included for bronchial artery embolization. Massive Hemoptysis is defined as bleeding more than 600ml / 24 hr. All patients will have a chest x-ray to lateralize the side of the bleeding. HRCT thorax will be done in some patients to know further about the lesions and bronchial and non-bronchial feeders before embolization. SAMPLE SIZE CALCULATION : Expected Sensitivity: 0.97 (13) Expected specificity: 0.91 (13) Prevalence of disease: 0.30 (14) Precision (± expected): 0.08 Confidence level 100(1- α): 95% Expected dropout rate: 5% Final Sample size (with 5% dropout) = 75 Statistical Analysis Data will be entered into a Microsoft Excel sheet, and statistical analysis will be done on the statistical software STATA 12. For descriptive statistics, mean ± standard deviation will be used, a median and interquartile range for quantitative variables, and a percentage with a number for categories. The relationship between various demographic, clinical characteristics and echocardiography diagnoses with the outcome will be evaluated by deploying the Chi-square test, Fischer’s exact test for categorical data, and an independent t-test for continuous data with normal distribution. Spearman (parametric) or Pearson (non-parametric) correlations will be applied to determine the association between dependent and independent variables. The p-value will be considered significant if less than 0.05. 
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