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Completed

NCT Number: NCT04771923

Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

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.

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Key information

Conditions

Bleeding Hemoptysis Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Tranexamic Acid

Drug

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

Adrenaline

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding

    Time frame: 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.

  2. Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline

    Time frame: During the first 24 hours immediately after the individual procedure (bronchoscopy).

    Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.

  3. Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.

    Time frame: 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).

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

    Time frame: 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).

  5. To compare number (N) of adverse events in each arm

    Time frame: During and up to 1 month after the procedure (bronchoscopy).

Sponsors and collaborators

Lead sponsor

Clinical Hospital Centre Zagreb

Other

Registry information

Official study title

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

Acronym: TAVA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2021
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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