BleedingTAVA2NCT06145191
Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy
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 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bleeding, Hemoptysis
- What is being tested?
- Tranexamic acid and Adrenaline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,013 participants
- Where
- 1 siteCroatia
- Study dates
- 18 Dec 2023to 28 Mar 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
- Signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
- 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: 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.
- Conditions
- Bleeding, Hemoptysis
- Being tested
- Tranexamic acid, Adrenaline, Placebo
- Keywords
- Bronchoscopy, Tranexamic acid, Adrenaline, Prophylaxis
- 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
Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
AdrenalineDrug
Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling
PlaceboDrug
Also called 0.9% NaCl
Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic acid |
| Adrenaline | Experimental | Not described Receives: Drug: Adrenaline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (N) of bleeding episodes / bleeding rate (%) in each group
Number of clinically relevant bleeding episodes after prophylactic application of tranexamic acid, adrenaline and placebo (0.9% NaCl)
Measured: through study completion, an average of 1.5 years
Secondary outcomes (5)
Severity of bleeding after prophylaxis
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
Measured: through study completion, an average of 1.5 years
Number (N) of drug applications needed for bleeding control
Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis
Measured: 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
Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)
Measured: through study completion, an average of 1.5 years
Number (N) of samples taken in each group
Mean total number (N) of samples taken in each group
Measured: through study completion, an average of 1.5 years
Adverse events
Number (N) of adverse events in each arm
Measured: through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start18 Dec 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multiple arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,013 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
- NCT06145191
- Sponsor's protocol ID
- 8.1-23/278-2; 02/013AG
- Acronym
- TAVA2
- Status last verified
- Jul 2025
- First submitted
- 13 Nov 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06145191
- Acronym / sponsor ID
- TAVA2 / 8.1-23/278-2; 02/013AG
- Conditions
- Bleeding, Hemoptysis
- Keywords
- Bronchoscopy, Tranexamic acid, Adrenaline, Prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 24 Nov 2023 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Multiple arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acid |
| Adrenaline | Experimental | Drug: Adrenaline |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
- Signed informed consent
Key exclusion criteria (10 listed)
- 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
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 acidProphylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling | Drug | Tranexamic acid |
| AdrenalineProphylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling | Drug | Adrenaline |
| PlaceboAlso: 0.9% NaClProphylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling | Drug | Placebo |
Primary outcome
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)
5 secondary outcomes
Severity of bleeding after prophylaxis
Time frame: 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 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
Number (N) of samples taken in each group
Time frame: through study completion, an average of 1.5 years
Adverse events
Time frame: through study completion, an average of 1.5 years
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 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Bleeding
Recruiting
Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards
Fallers Aged 60 Years and Older, Biomarkers / Blood
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Enrolling by invitationEarly Phase 1
Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.
Moyamoya Disease
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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 2 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 1 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
Number (N) of bleeding episodes / bleeding rate (%) in each group (time frame: through study completion, an average of 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.