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OpenTrials
Completed

NCT Number: NCT06145191

Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

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.

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Key information

Conditions

Bleeding Hemoptysis Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Tranexamic Acid

Drug

Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling

Adrenaline

Drug

Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling

Placebo

Drug

Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling

Other names: 0.9% NaCl

Primary outcomes

  1. Number (N) of bleeding episodes / bleeding rate (%) in each group

    Time frame: through study completion, an average of 1.5 years

    Number of clinically relevant bleeding episodes after prophylactic application of tranexamic acid, adrenaline and placebo (0.9% NaCl)

Secondary outcomes

  1. Severity of bleeding after prophylaxis

    Time frame: through study completion, an average of 1.5 years

    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

  2. Number (N) of drug applications needed for bleeding control

    Time frame: through study completion, an average of 1.5 years

    Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis

  3. Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication

    Time frame: through study completion, an average of 1.5 years

    Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)

  4. Number (N) of samples taken in each group

    Time frame: through study completion, an average of 1.5 years

    Mean total number (N) of samples taken in each group

  5. Adverse events

    Time frame: through study completion, an average of 1.5 years

    Number (N) of adverse events in each arm

Sponsors and collaborators

Lead sponsor

Clinical Hospital Centre Zagreb

Other

Registry information

Official study title

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

Acronym: TAVA2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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