Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding (TAVA)
Primary Purpose
Bleeding, Hemoptysis
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Tranexamic acid
Adrenaline
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding focused on measuring Bronchoscopy, Tranexamic acid, Adrenaline
Eligibility Criteria
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%)
Sites / Locations
- Clinical Hospital Centre Zagreb
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tranexamic acid
Adrenaline
Arm Description
Outcomes
Primary Outcome Measures
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
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
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
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.
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
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
Full Information
NCT ID
NCT04771923
First Posted
February 18, 2021
Last Updated
February 22, 2022
Sponsor
Clinical Hospital Centre Zagreb
1. Study Identification
Unique Protocol Identification Number
NCT04771923
Brief Title
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding
Acronym
TAVA
Official Title
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Hemoptysis
Keywords
Bronchoscopy, Tranexamic acid, Adrenaline
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Title
Adrenaline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Intervention Description
Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.
Primary Outcome Measure Information:
Title
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
Description
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Secondary Outcome Measure Information:
Title
Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding
Description
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..
Title
Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline
Description
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.
Time Frame
During the first 24 hours immediately after the individual procedure (bronchoscopy).
Title
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.
Description
As assessed by the bronchoscopist by visual analogue scale (VAS) 1-10 (1 very mild - 10 very severe).
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..
Title
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
Description
In different indications and methods (transbronchial lung biopsy, endobronchial biopsy, transbronchial needle aspiration, bronchial brushing).
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Title
To compare number (N) of adverse events in each arm
Time Frame
During and up to 1 month after the procedure (bronchoscopy).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%)
Facility Information:
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
36273651
Citation
Badovinac S, Glodic G, Sabol I, Dzubur F, Makek MJ, Baricevic D, Korsic M, Popovic F, Srdic D, Samarzija M. Tranexamic Acid vs Adrenaline for Controlling Iatrogenic Bleeding During Flexible Bronchoscopy: A Double-Blind Randomized Controlled Trial. Chest. 2023 Apr;163(4):985-993. doi: 10.1016/j.chest.2022.10.013. Epub 2022 Oct 21.
Results Reference
derived
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Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding
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