Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,013
- Locations
- 1
- Primary Endpoint
- Number (N) of bleeding episodes / bleeding rate (%) in each group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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%)
Arms & Interventions
Tranexamic acid
Intervention: Tranexamic acid (Drug)
Adrenaline
Intervention: Adrenaline (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Number (N) of drug applications needed for bleeding control(through study completion, an average of 1.5 years)
- Severity of bleeding after prophylaxis(through study completion, an average of 1.5 years)
- Adverse events(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(through study completion, an average of 1.5 years)
- Number (N) of samples taken in each group(through study completion, an average of 1.5 years)
Investigators
Goran Glodić
MD
Clinical Hospital Centre Zagreb