Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

Study Overview
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Brief Summary
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Endobronchial bleeding is a relatively common complication of diagnostic bronchoscopy. Both tranexamic acid and adrenaline are used topically for the control of endobronchial bleeding. The aim of this study is to compare the efficacy of tranexamic acid with adrenaline in controlling iatrogenic endobronchial bleeding after diagnostic bronchoscopy.

Official Title
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Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial

Conditions
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Bleeding, Hemoptysis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec) Exclusion Criteria: Any patient with a contraindication for diagnostic flexible bronchoscopy Coagulopathy (PV INR >1.3) Thrombocytopenia (<50x10^9) or anemia (hgb <80 g/L) Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy Thrombophilia, history of pulmonary embolism or deep vein thrombosis Contraindication for endobronchial application of adrenaline Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia 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

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br> | Drug: Tranexamic acid<br>* Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.<br>|
| Experimental: Adrenaline<br> | Drug: Adrenaline<br>* Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm | Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation. | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding | Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation. | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.. | 
| Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline | Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention. | During the first 24 hours immediately after the individual procedure (bronchoscopy). | 
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding. | As assessed by the bronchoscopist by visual analogue scale (VAS) 1-10 (1 very mild - 10 very severe). | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.. | 
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm | In different indications and methods (transbronchial lung biopsy, endobronchial biopsy, transbronchial needle aspiration, bronchial brushing). | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application. | 
| To compare number (N) of adverse events in each arm |  | During and up to 1 month after the procedure (bronchoscopy). | 

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