Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

Not Applicable

Completed

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

• Registration Number: NCT04771923
• Lead Sponsor: Clinical Hospital Centre Zagreb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study Start: 2021-02-22
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Status Verified: 2022-02
• Primary Completion: 2022-02-04
• Study Completion: 2022-02-04
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic acid	-
Adrenaline	Adrenaline	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia