An interventional study of Tranexamic acid and Adrenaline in Bleeding and Hemoptysis, sponsored by Clinical Hospital Centre Zagreb. Completed at 1 site in Croatia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Clinical Hospital Centre Zagreb · Not applicable, Interventional, and Prevention
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's enrollment of 1,013 is above the median of 73 across 20 interventional studies indexed under Hemoptysis.
Browse Hemoptysis studies →Clinical Hospital Centre Zagreb is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
Compared within Hemoptysis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hemorrhage. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tranexamic acid
Drug: Adrenaline
Drug: Placebo
Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling
Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling
Also known as: 0.9% NaCl
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)
Time frame: through study completion, an average of 1.5 years
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
Time frame: 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
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
Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)
Time frame: 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
Time frame: through study completion, an average of 1.5 years
Adverse events
Number (N) of adverse events in each arm
Time frame: through study completion, an average of 1.5 years
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tranexamic Acid · Epinephrine
Clinical Hospital Centre Zagreb