Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

Bleeding Clinical Trial

— TAVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771923
• Other study ID #: 8.1-21/20-2; 02/21AG
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: February 2022
• Source: Clinical Hospital Centre Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Bleeding
• Hemoptysis
• Hemorrhage

Intervention

Drug:
• Tranexamic acid
Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
• Adrenaline
Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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..
Secondary	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).
Secondary	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..
Secondary	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.
Secondary	To compare number (N) of adverse events in each arm		During and up to 1 month after the procedure (bronchoscopy).