BleedingTAVANCT04771923
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding
A study testing Tranexamic acid and Adrenaline in people with Bleeding and Hemoptysis, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Hemoptysis
- What is being tested?
- Tranexamic acid and Adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCroatia
- Study dates
- 22 Feb 2021to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)
Who cannot join
- 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
Show all 10Show fewer
- Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia
- Uncontrolled pulmonary hypertension
- Cardiovascular decompensation
- Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bleeding, Hemoptysis
- Being tested
- Tranexamic acid, Adrenaline
- Keywords
- Bronchoscopy, Tranexamic acid, Adrenaline
- Medical subject headings
- Hemorrhage, Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
AdrenalineDrug
Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic acid |
| Adrenaline | Experimental | Not described Receives: Drug: Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
Measured: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Secondary outcomes (5)
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.
Measured: 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
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.
Measured: 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.
As assessed by the bronchoscopist by visual analogue scale (VAS) 1-10 (1 very mild - 10 very severe).
Measured: 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
In different indications and methods (transbronchial lung biopsy, endobronchial biopsy, transbronchial needle aspiration, bronchial brushing).
Measured: 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
Measured: During and up to 1 month after the procedure (bronchoscopy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start22 Feb 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Glodić, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771923
- Sponsor's protocol ID
- 8.1-21/20-2; 02/21AG
- Acronym
- TAVA
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36273651
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04771923
- Acronym / sponsor ID
- TAVA / 8.1-21/20-2; 02/21AG
- Conditions
- Bleeding, Hemoptysis
- Keywords
- Bronchoscopy, Tranexamic acid, Adrenaline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acid |
| Adrenaline | Experimental | Drug: Adrenaline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidTopical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline. | Drug | Tranexamic acid |
| AdrenalineTopical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid. | Drug | Adrenaline |
Primary outcome
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.
5 secondary outcomes
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..
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).
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..
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.
To compare number (N) of adverse events in each arm
Time frame: During and up to 1 month after the procedure (bronchoscopy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 36273651Badovinac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and Adrenaline in people with Bleeding and Hemoptysis, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.