Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy (TAVA2)

Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial

Endobronchial bleeding is a common complication of bronchoscopy. Major bleeding, although rare, can be life threatening and often requires advanced therapeutic interventional pulmonary procedures which are not widely available. Minor bleeding can negatively impact outcomes such as diagnostic yield, sample size and bronchoscopy duration. Both adrenaline and tranexamic acid are successfully used topically for hemostasis during diagnostic bronchoscopy. The aim of this study is to evaluate the efficacy of prophylactically applied adrenaline and tranexamic acid in bleeding prevention during diagnostic bronchoscopy.

Study Overview

• Status: Completed
• Conditions: Bleeding; Hemoptysis
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Adrenaline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1013
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
• Signed informed consent

Exclusion Criteria:

• Any existing contraindication for diagnostic bronchoscopy
• Coagulopathy (PV INR > 1.3)
• Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L)
• DOAC, LMWH or antiplatelet drug therapy
• Thrombophilia, history of pulmonary embolism or deep vein thrombosis
• Contraindication for endobronchial application of adrenaline
• Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
• Uncontrolled pulmonary hypertension
• Cardiovascular decompensation
• Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling; Other Names: 0.9% NaCl
Experimental: Tranexamic acid	Drug: Tranexamic acid; Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
Experimental: Adrenaline	Drug: Adrenaline; Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (N) of bleeding episodes / bleeding rate (%) in each group	Number of clinically relevant bleeding episodes after prophylactic application of tranexamic acid, adrenaline and placebo (0.9% NaCl)	through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of bleeding after prophylaxis	Mean severity of bleeding assessed by a visual analogue scale (VAS; 1 minor bleeding - 10 major life threatening bleeding) by the operating bronchoscopist in each group	through study completion, an average of 1.5 years
Number (N) of drug applications needed for bleeding control	Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis	through study completion, an average of 1.5 years
Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication	Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)	through study completion, an average of 1.5 years
Number (N) of samples taken in each group	Mean total number (N) of samples taken in each group	through study completion, an average of 1.5 years
Adverse events	Number (N) of adverse events in each arm	through study completion, an average of 1.5 years

Collaborators and Investigators

• Sponsor: Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Bronchoscopy; Prophylaxis; Adrenaline; Tranexamic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Hemorrhage; Hemoptysis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Tranexamic Acid; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 8.1-23/278-2; 02/013AG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No