Clinical trial NCT04771923: Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding
Official title: Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Hemoptysis
Keywords: Bronchoscopy
Tranexamic acid
Adrenaline
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)

Exclusion Criteria:

* Any patient with a contraindication for diagnostic flexible bronchoscopy
* Coagulopathy (PV INR \>1.3)
* Thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/L)
* Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy
* Thrombophilia, history of pulmonary embolism or deep vein thrombosis
* Contraindication for endobronchial application of adrenaline
* Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia
* Uncontrolled pulmonary hypertension
* Cardiovascular decompensation
* Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)

Primary outcomes:
measure: Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
timeFrame: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Secondary outcomes:
measure: Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding
timeFrame: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..
measure: Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline
timeFrame: During the first 24 hours immediately after the individual procedure (bronchoscopy).
measure: Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.
timeFrame: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..
measure: Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
timeFrame: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
measure: To compare number (N) of adverse events in each arm
timeFrame: During and up to 1 month after the procedure (bronchoscopy).
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
Study officials:
References:
citation: 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.