TAVA2: Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

Sponsor

Clinical Hospital Centre Zagreb (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06145191

Collaborator

(none)

840

Enrollment

Location

Arms

Anticipated Duration (Months)

46.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Hemoptysis	Drug: Tranexamic acid Drug: Adrenaline Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

840 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multiple arm randomized controlled trialMultiple arm randomized controlled trial

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranexamic acid	Drug: Tranexamic acid Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling
Experimental: Adrenaline	Drug: Adrenaline Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling
Placebo Comparator: Placebo	Drug: Placebo Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling Other Names: 0.9% NaCl

Arm

Intervention/Treatment

Experimental: Tranexamic acid

Drug: Tranexamic acid

Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling

Experimental: Adrenaline

Drug: Adrenaline

Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling

Placebo Comparator: Placebo

Drug: Placebo

Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling

Other Names:

0.9% NaCl

Outcome Measures

Primary Outcome Measures

Number (N) of bleeding episodes / bleeding rate (%) in each group [through study completion, an average of 1.5 years]
Number of clinically relevant bleeding episodes after prophylactic application of tranexamic acid, adrenaline and placebo (0.9% NaCl)

Secondary Outcome Measures

Severity of bleeding after prophylaxis [through study completion, an average of 1.5 years]
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
Number (N) of drug applications needed for bleeding control [through study completion, an average of 1.5 years]
Number (N) of drug applications needed for bleeding control in each group if bleeding occured despite prophylaxis
Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication [through study completion, an average of 1.5 years]
Bleeding rate in different subgroups of patients (i.e. TBNA, forceps biopsy, brush)
Number (N) of samples taken in each group [through study completion, an average of 1.5 years]
Mean total number (N) of samples taken in each group
Adverse events [through study completion, an average of 1.5 years]
Number (N) of adverse events in each arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
Signed informed consent