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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,013
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
University Hospital Centre Zagreb
Zagreb, Croatia
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
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