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 and older. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Clinical Hospital Centre Zagreb · Not applicable, Interventional, and Treatment
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's enrollment of 130 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 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.
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.
Drug: Tranexamic acid
Drug: Adrenaline
Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
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.
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.
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
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.
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.
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..
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).
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).
This study is completed, as verified in Feb 2022. 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