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Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding (TAVA)

C

Clinical Hospital Centre Zagreb

Status

Completed

Conditions

Hemoptysis
Bleeding

Treatments

Drug: Tranexamic acid
Drug: Adrenaline

Study type

Interventional

Funder types

Other

Identifiers

NCT04771923
8.1-21/20-2 02/21AG;

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

130 participants in 2 patient groups

Tranexamic acid
Experimental group
Treatment:
Drug: Tranexamic acid
Adrenaline
Experimental group
Treatment:
Drug: Adrenaline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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