Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

NCT06145191 | Completed

• 1 other identifier: 8.1-23/278-2; 02/013AG
• Study Type: interventional
• Target: 1,013
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding; Hemoptysis

Keywords

Bronchoscopy; Tranexamic acid; Adrenaline; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Severity of bleeding after prophylaxis

  through study completion, an average of 1.5 years

• Number (N) of drug applications needed for bleeding control

  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

  through study completion, an average of 1.5 years

• Number (N) of samples taken in each group

  through study completion, an average of 1.5 years

• Adverse events

  through study completion, an average of 1.5 years

Study Arms (3)

Tranexamic acid

EXPERIMENTAL

Drug: Tranexamic acid

Adrenaline

EXPERIMENTAL

Drug: Adrenaline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tranexamic acid DRUG

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

Tranexamic acid

Adrenaline DRUG

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

Adrenaline

Placebo DRUG

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

Also known as: 0.9% NaCl

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Hemorrhage; Hemoptysis

Interventions

Tranexamic Acid; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Multiple arm randomized controlled trial

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 24, 2023
• Study Start: December 18, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)