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Clinical Trials/NCT06145191
NCT06145191CompletedNot Applicable

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

Clinical Hospital Centre Zagreb1 site in 1 country1,013 target enrollmentStarted: December 18, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,013
Locations
1
Primary Endpoint
Number (N) of bleeding episodes / bleeding rate (%) in each group

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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%)

Arms & Interventions

Tranexamic acid

Experimental

Intervention: Tranexamic acid (Drug)

Adrenaline

Experimental

Intervention: Adrenaline (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Number (N) of bleeding episodes / bleeding rate (%) in each group

Time Frame: 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 Outcomes

  • Number (N) of drug applications needed for bleeding control(through study completion, an average of 1.5 years)
  • Severity of bleeding after prophylaxis(through study completion, an average of 1.5 years)
  • Adverse events(through study completion, an average of 1.5 years)
  • 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)
  • Number (N) of samples taken in each group(through study completion, an average of 1.5 years)

Investigators

Sponsor
Clinical Hospital Centre Zagreb
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Goran Glodić

MD

Clinical Hospital Centre Zagreb

Study Sites (1)

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