Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy (TAVA2)

Clinical Hospital Centre Zagreb

Status: Completed

Conditions: Hemoptysis; Bleeding

Treatments: Drug: Adrenaline; Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06145191

8.1-23/278-2 02/013AG;

Details and patient eligibility

About

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.

Enrollment: 1,013 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,013 participants in 3 patient groups, including a placebo group

Tranexamic acid

Experimental group

Treatment:

Drug: Tranexamic acid

Adrenaline

Experimental group

Treatment:

Drug: Adrenaline

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo