Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding (TAVA)

February 22, 2022 updated by: Goran Glodić, Clinical Hospital Centre Zagreb

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centre Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: During the first 24 hours immediately after the individual procedure (bronchoscopy).
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.
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.
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).
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
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).
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
Time Frame: During and up to 1 month after the procedure (bronchoscopy).
During and up to 1 month after the procedure (bronchoscopy).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Centre Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

February 4, 2022

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.1-21/20-2; 02/21AG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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