Bleeding, Hemoptysis
Conditions
Keywords
Bronchoscopy, Tranexamic acid, Adrenaline
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.
Interventions
DRUGTranexamic acid
Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
DRUGAdrenaline
Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.
Sponsors
Clinical Hospital Centre Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding | 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. |
| Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline | During the first 24 hours immediately after the individual procedure (bronchoscopy). | 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. | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.. | 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 | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application. | 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 | During and up to 1 month after the procedure (bronchoscopy). | — |
Countries
Croatia
Outcome results
None listed