Bleeding, Hemoptysis
Conditions
Keywords
Bronchoscopy, Tranexamic acid, Adrenaline, Prophylaxis
Brief 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. 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.
Interventions
DRUGTranexamic acid
Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
DRUGAdrenaline
Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling
DRUGPlacebo
Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling
Sponsors
Clinical Hospital Centre Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Multiple arm randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration) * Signed informed consent
Exclusion criteria
* 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 * Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia * Uncontrolled pulmonary hypertension * Cardiovascular decompensation * Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (N) of bleeding episodes / bleeding rate (%) in each group | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of bleeding after prophylaxis | through study completion, an average of 1.5 years | 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 |
| Number (N) of drug applications needed for bleeding control | through study completion, an average of 1.5 years | Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis |
| Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication | through study completion, an average of 1.5 years | Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush) |
| Number (N) of samples taken in each group | through study completion, an average of 1.5 years | Mean total number (N) of samples taken in each group |
| Adverse events | through study completion, an average of 1.5 years | Number (N) of adverse events in each arm |
Countries
Croatia
Outcome results
None listed