| 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
|
|
|
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
|
|
|
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
|
|
|
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. |