Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Bleeding, Hemoptysis

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Adrenaline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multiple arm randomized controlled trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Tranexamic acid, Adrenaline, Prophylaxis