Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental |
| |
| Adrenaline | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through study completion, an average of 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1.5 years |
| Number (N) of drug applications needed for bleeding control |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D006469 | Hemoptysis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D004837 | Epinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Multiple arm randomized controlled trial
Not provided
Not provided
Not provided
| Adrenaline | Drug | Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling |
|
| Placebo | Drug | Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling |
|
|
Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis |
| 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) | 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 | through study completion, an average of 1.5 years |
| Adverse events | Number (N) of adverse events in each arm | through study completion, an average of 1.5 years |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |