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CTRI Number  CTRI/2019/05/019147 [Registered on: 15/05/2019] Trial Registered Prospectively
Last Modified On: 10/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   To study the severity of bleeding during Transbronchial lung biopsy. 
Scientific Title of Study   To study the incidence and severity of endobronchial bleeding during Transbronchial lung biopsy (TBLB) procedure in patients without known clinical risk factors for increased bleeding: A Prospective observational study. 
Trial Acronym  BRIL Study (Bleeding Risk in Lung Biopsy) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MATHEW VARGHESE NELLIMOOTIL 
Designation  Post graduate Registrar 
Affiliation  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Pulmonary Medicine, Christian Medical college and hospital. Vellore. Tamil nadu -632004
57-3/3, Christian Medical college and hospital. Vellore. Tamil nadu -632004
Vellore
TAMIL NADU
632004
India 
Phone  07397139226  
Fax    
Email  mathew3786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prince James 
Designation  Professor 
Affiliation  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Pulmonary Medicine, Christian Medical college and hospital. Vellore. Tamil nadu -632004

Vellore
TAMIL NADU
632004
India 
Phone  9600771709  
Fax    
Email  drprincej@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MATHEW VARGHESE NELLIMOOTIL 
Designation  Post graduate Registrar 
Affiliation  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Pulmonary disease, Christian Medical college and hospital. Vellore. Tamil nadu -632004
57-3/3, Christian Medical college and hospital. Vellore. Tamil nadu -632004
Vellore
TAMIL NADU
632004
India 
Phone  07397139226  
Fax    
Email  mathew3786@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Fund. Christian Medical College and Hospital, Vellore. Tamil Nadu 632 004 
 
Primary Sponsor  
Name  Fluid Research Fund 
Address  Christian Medical College and Hospital. Vellore. Tamil nadu 632004 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Mathew Varghese Nellimootil  Christian Medical College and Hospital, Vellore  Bronchoscopy Suite,Department of Pulmonary Medicine, Christian Medical college and Hospital, Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU 
07397139226

mathew3786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J95||Intraoperative and postproceduralcomplications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All male and female patients above the age of 18 years presenting to the department of Pulmonary Medicine department of CMC for Transbronchial Lung biopsy 
 
ExclusionCriteria 
Details  -Known bleeding diathesis
-Pregnant women
-Thrombocytopenia
-Chronic Kidney Disease
-Chronic Liver Disease patients
-Patients on Chemotherapy
-Post Lung transplant
-History of significant bleeding -post operative or trauma
-History of severe epistaxis, GI bleed, hematuria, menorrhagia, petechiae,
-Treatment with Anticoagulants
-Patients in sepsis with shock or disseminated intravascular coagulation
-Patients with low respiratory reserve
-All patients who do not consent to the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the incidence and severity of endobronchial bleeding during Transbronchial lung biopsy (TBLB) procedure.  May 2019 to June 2020 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the etiology of moderate to severe endobronchial bleeding in patients undergoing transbronchial biopsy procedure, in the department of pulmonary medicine.
2.To find the difference in proportion of patients with significant endobronchial bleeding during TBLB procedure performed for different lung pathologies.
 
May 2019 to June 2020 
 
Target Sample Size   Total Sample Size="436"
Sample Size from India="436" 
Final Enrollment numbers achieved (Total)= "289"
Final Enrollment numbers achieved (India)="289" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/05/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2020 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Transbronchial lung biopsy (TBLB) is performed during flexible bronchoscopy in order to sample tissues. It is useful in patients with localized lung lesions, fungal or mycobacterial infections and in lung malignancy. Although the procedure is relatively safe, complications such as pneumothorax and hemorrhage have been reported following TBLB. Current guidelines do   not recommend routine pre-procedural studies of coagulation parameters, unless they are known or are likely to have coagulation abnormalities. However, in CMC, we routinely screen all our patients. It is believed that it would result in reduction of bleeding risk, but there is no evidence to support this practice.  Therefore, we want to assess if our protocol for routine screening is providing added benefit to the patients in decreasing the post procedural bleeding.

For our study, we intend to identify patients with known clinical risk factors for increased bleeding and follow the recommended protocol of screening them for coagulation abnormalities, and if present and when required, to obtain clearance for procedure from the clinical hematologists prior to the procedure. If recommended, they will be given blood products prior to the procedure. These patients will be excluded from our study.

The patients who do not have clinical risk factors will be recruited. Coagulation parameters will   be measured in these subjects. The procedures in these patients will be monitored and measurement of bleeding and all other relevant variables will be obtained. The physician doing the bronchoscopy procedure will be blinded to coagulation parameters of both arms. The amount of bleeding will be quantified (in grams/dl of Hemoglobin) as well as interpreted as mild, moderate and severe bleeding by the bronchoscopist. The frequency and quantity of bleed in group of patients with abnormal bleeding parameters will be compared with those with normal bleeding parameters.We will also look for other possible etiological causes of increase risk of bleeding like Pulmonary Hypertension, history of Aspirin intake, Vasculitis, Cavitating lesions, SVC syndrome, multiple biopsies from 1 to 3 segment vs more than 3 segments, 3 to 5 biopsy pieces versus more than 5 biopsy pieces etc.

 
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