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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental |
| |
| Adrenaline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm | Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation. | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application. |
| Measure | Description | Time Frame |
|---|---|---|
| Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding | Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation. | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.. |
| Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36273651 | Derived | Badovinac S, Glodic G, Sabol I, Dzubur F, Makek MJ, Baricevic D, Korsic M, Popovic F, Srdic D, Samarzija M. Tranexamic Acid vs Adrenaline for Controlling Iatrogenic Bleeding During Flexible Bronchoscopy: A Double-Blind Randomized Controlled Trial. Chest. 2023 Apr;163(4):985-993. doi: 10.1016/j.chest.2022.10.013. Epub 2022 Oct 21. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D006469 | Hemoptysis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Adrenaline | Drug | Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid. |
|
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention. |
| During the first 24 hours immediately after the individual procedure (bronchoscopy). |
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding. | As assessed by the bronchoscopist by visual analogue scale (VAS) 1-10 (1 very mild - 10 very severe). | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.. |
| Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm | In different indications and methods (transbronchial lung biopsy, endobronchial biopsy, transbronchial needle aspiration, bronchial brushing). | Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application. |
| To compare number (N) of adverse events in each arm | During and up to 1 month after the procedure (bronchoscopy). |
| 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 |