Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

N/ACompletedNCT04771923

Clinical Hospital Centre Zagreb130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Bleeding Hemoptysis

Interventions

Tranexamic acidDRUG

Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.

AdrenalineDRUG

Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%)

Locations (1)

Clinical Hospital Centre Zagreb

Zagreb, Croatia

Outcomes

Primary Outcomes

Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm

Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.

Time frame: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.