Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

Bleeding Clinical Trial

— TAVA2  

Official title:

Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145191
• Other study ID #: 8.1-23/278-2; 02/013AG
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: May 2025

Study information

• Verified date: December 2023
• Source: Clinical Hospital Centre Zagreb
• Contact: Sonja Badovinac, MD, PhD
• Phone: 00385(1)2385129
• Email: sonjabadovinac1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Bleeding
• Hemoptysis
• Hemorrhage

Intervention

Drug:
• Tranexamic acid
Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
• Adrenaline
Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling
• Placebo
Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling

Locations

Country	Name	City	State
Croatia	University Hospital Centre Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	through study completion, an average of 1.5 years
Secondary	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
Secondary	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
Secondary	Adverse events	Number (N) of adverse events in each arm	through study completion, an average of 1.5 years