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Study using nebulized tranexamic acid to look for increased yield of biopsy specimens obtained during conventional endobronchial biopsies obtained

Efficacy of nebulized tranexamic acid in improving yield during endobronchial biopsies. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074877
Enrollment
129
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J984- Other disorders of lung

Interventions

Intervention1: NEBULIZATION WITH TRANEXAMIC ACID BEFORE STARTING ENDOBRONCHIAL BIOPSIES: intervention group subjects will be nebulised with tranexamic acid at a dose of 500mg(5ml) of intravenous formu

Sponsors

PGIMS ROHTAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients aged =18 years posted for fiberoptic bronchoscopy with a plan for obtaining endobronchial biopsy.

Exclusion criteria

Exclusion criteria: 1) Active and ongoing pulmonary bleeding (haemoptysis), 2) Known history of bleeding predisposition, 3) Decompensated liver disease, 4) Kidney disease (an estimated glomerular filtration rate of =30 ml/min), 5) Known allergy to tranexamic acid

Design outcomes

Primary

MeasureTime frame
Efficacy of nebulized tranexamic acid in increasing the adequacy of endobronchial biopsy.Timepoint: Adequate sample will be defined as biopsy sample sufficient for histopathology, immunohistochemistry, and molecular analysis.

Secondary

MeasureTime frame
To assess the efficacy to control bleeding during endobronchial biopsy.Timepoint: Severity of bleeding: Mild: requiring continuous suctioning and bleeding stopped spontaneously. Moderate: requiring use of cold saline or epinephrine to control bleeding. Severe: placement of bronchial blocker /balloon catheter/ applying fibrin sealant, fluid resuscitation/ blood transfusion, admission to critical care unit or death.;To assess the number and size of biopsies obtained.Timepoint: Number of biopsies will be determined based upon successful passes taken and size will be compared with the cup of the forceps, small- cup is bigger than tissue,Medium- tissue fills the cup, large- tissue is largen than the cup;To assess the procedure length.Timepoint: Length of the procedure from nebulization with study agent to end of the procedure. Length of the procedure as assessed from introduction of scope to the end of the procedure.;To assess the safety of nebulized tranexamic acid just prior to endobronchial biopsy.Timepoint: Incidence and frequency all adverse events and SAEs will be reported as per the CTCAE Version 5.0.

Countries

India

Contacts

Public ContactVineela Surapaneni

Pandit B.D Sharma, PGIMS, Rohtak

dhruvachaudhry@yahoo.co.in9991101616

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026