TAVA: Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

Sponsor

Clinical Hospital Centre Zagreb (Other)

Overall Status

Completed

CT.gov ID

NCT04771923

Collaborator

(none)

130

Enrollment

Location

Arms

11.4

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Hemoptysis	Drug: Tranexamic acid Drug: Adrenaline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2021

Actual Primary Completion Date :

Feb 4, 2022

Actual Study Completion Date :

Feb 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranexamic acid	Drug: Tranexamic acid Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
Experimental: Adrenaline	Drug: Adrenaline Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.

Arm

Intervention/Treatment

Experimental: Tranexamic acid

Drug: Tranexamic acid

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

Experimental: Adrenaline

Drug: Adrenaline

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

Outcome Measures

Primary Outcome Measures

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

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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%)