Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy (TAVA2)

December 22, 2023 updated by: Goran Glodić, Clinical Hospital Centre Zagreb

Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial

Endobronchial bleeding is a common complication of bronchoscopy. Major bleeding, although rare, can be life threatening and often requires advanced therapeutic interventional pulmonary procedures which are not widely available. Minor bleeding can negatively impact outcomes such as diagnostic yield, sample size and bronchoscopy duration. Both adrenaline and tranexamic acid are successfully used topically for hemostasis during diagnostic bronchoscopy. The aim of this study is to evaluate the efficacy of prophylactically applied adrenaline and tranexamic acid in bleeding prevention during diagnostic bronchoscopy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

840

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 Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
  • Signed informed consent

Exclusion Criteria:

  • Any existing contraindication for diagnostic bronchoscopy
  • Coagulopathy (PV INR > 1.3)
  • Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L)
  • DOAC, LMWH or antiplatelet drug therapy
  • Thrombophilia, history of pulmonary embolism or deep vein thrombosis
  • Contraindication for endobronchial application of adrenaline
  • Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
  • 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling
Other Names:
  • 0.9% NaCl
Experimental: Tranexamic acid
Drug: Tranexamic acid
Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
Experimental: Adrenaline
Drug: Adrenaline
Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (N) of bleeding episodes / bleeding rate (%) in each group
Time Frame: through study completion, an average of 1.5 years
Number of clinically relevant bleeding episodes after prophylactic application of tranexamic acid, adrenaline and placebo (0.9% NaCl)
through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of bleeding after prophylaxis
Time Frame: through study completion, an average of 1.5 years
Mean severity of bleeding assessed by a visual analogue scale (VAS; 1 minor bleeding - 10 major life threatening bleeding) by the operating bronchoscopist in each group
through study completion, an average of 1.5 years
Number (N) of drug applications needed for bleeding control
Time Frame: through study completion, an average of 1.5 years
Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis
through study completion, an average of 1.5 years
Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication
Time Frame: through study completion, an average of 1.5 years
Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)
through study completion, an average of 1.5 years
Number (N) of samples taken in each group
Time Frame: through study completion, an average of 1.5 years
Mean total number (N) of samples taken in each group
through study completion, an average of 1.5 years
Adverse events
Time Frame: through study completion, an average of 1.5 years
Number (N) of adverse events in each arm
through study completion, an average of 1.5 years

Collaborators and Investigators

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

Sponsor

Clinical Hospital Centre Zagreb

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)

December 18, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.1-23/278-2; 02/013AG

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.

Clinical Trials on Bleeding

Clinical Trials on Tranexamic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe