Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

Not Applicable

Recruiting

• Conditions: Bleeding; Hemoptysis
• Interventions: Drug: Tranexamic acid; Drug: Adrenaline; Drug: Placebo

• Registration Number: NCT06145191
• Lead Sponsor: Clinical Hospital Centre Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-24
• Study Start: 2023-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic acid	-
Adrenaline	Adrenaline	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number (N) of bleeding episodes / bleeding rate (%) in each group	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 Outcome Measures

Name	Time	Method
Number (N) of drug applications needed for bleeding control	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
Severity of bleeding after prophylaxis	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
Adverse events	through study completion, an average of 1.5 years	Number (N) of adverse events in each arm
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	Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)
Number (N) of samples taken in each group	through study completion, an average of 1.5 years	Mean total number (N) of samples taken in each group

Trial Locations

Locations (1)

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia