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Completed

NCT Number: NCT07759089

The Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding

During bronchoscopy (a procedure using a thin, flexible camera to look inside the airways), doctors sometimes take small tissue samples (biopsies) to diagnose lung conditions. This can cause bleeding in the airway. Doctors currently use a medicine called adrenaline to stop this bleeding, but it doesn't always work, and bleeding can come back afterward. Another medicine, tranexamic acid, may work better because it helps blood clot and stay clotted, rather than just narrowing the blood vessels.

This study compared tranexamic acid and adrenaline, both given directly onto the bleeding site through the bronchoscope, in patients who developed moderate bleeding after a biopsy. The goal was to find out which medicine stopped the bleeding better right away, and which one was less likely to let the bleeding start again within 30 minutes.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Hospital

Lahore, Punjab Province, 54470, Pakistan

About this study

This was a randomized controlled trial conducted at the Department of Pulmonology, Shaikh Zayed Hospital, Federal Postgraduate Medical Institute, Lahore, Pakistan, over a 12-month period. Adult patients undergoing diagnostic flexible bronchoscopy with endobronchial forceps biopsy who developed moderate post-biopsy bleeding (bleeding that obscured the bronchoscopic view and required repeated suctioning and endoscopic intervention, but without hemodynamic instability) were randomized by lottery method into two equal groups (n=38 each).

Group A received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; 0.05 mg/mL), and Group B received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; 25 mg/mL). The assigned drug was instilled directly onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, with administration repeated up to three times at 30-second intervals if bleeding persisted.

The primary outcome was immediate hemostasis, defined as cessation of oozing and/or formation of a stable clot within 90 seconds of drug instillation. The secondary outcome was rebleeding within 30 minutes of initial hemostasis, assessed by repeat bronchoscopic inspection. If bleeding persisted beyond 90 seconds despite maximal drug administration, this was classified as treatment failure, and rescue measures (cold saline, crossover drug instillation, wedge tamponade, electrocautery, or argon plasma coagulation) were used.

Demographic and clinical data (age, gender, BMI, smoking status, symptom duration, diabetes, hypertension) were recorded, and stratified subgroup analyses were performed. Statistical analysis used the Chi-square test for intergroup comparisons, with p≤0.05 considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients of any age and gender undergoing diagnostic flexible bronchoscopy for suspected benign or malignant airway disease
  • Required endobronchial forceps biopsy during the procedure
  • Developed moderate endobronchial bleeding following biopsy (defined as bleeding that obscured the bronchoscopic view, required repeated suctioning to clear the airway, and required endoscopic intervention for hemostasis, but remained hemodynamically stable)

Exclusion criteria

  • Severe bleeding (requiring instillation of ice-cold saline, bronchoscopic tamponade, electrocautery, or argon plasma coagulation)
  • Life-threatening bleeding (requiring endotracheal intubation, or spontaneous hemoptysis of more than 100-150 mL per hour)
  • Contraindications to bronchoscopy, including:
  • Cardiac arrhythmias
  • Oxygen saturation below 90% on supplemental oxygen
  • Acute respiratory failure with hypercapnia
  • Tracheal obstruction
  • Bleeding diathesis with raised INR or platelet count less than 50,000/mm³
  • Unstable coronary artery disease
  • Hypersensitivity to tranexamic acid or adrenaline

Treatment and study plan

Adrenaline

Drug

1 mg adrenaline diluted in 20 mL normal saline (0.05 mg/mL), administered topically via bronchoscope working channel in 5 mL aliquots, up to 3 applications at 30-second intervals.

Tranexamic Acid

Drug

500 mg tranexamic acid diluted in 20 mL normal saline (25 mg/mL), administered topically via bronchoscope working channel in 5 mL aliquots, up to 3 applications at 30-second intervals.

Primary outcomes

  1. Immediate Hemostasis (Bleeding Cessation)

    Time frame: Within 90 seconds of drug instillation

    Immediate bleeding control, defined as direct bronchoscopic observation of cessation of oozing and/or formation of a stable clot at the bleeding site, assessed within 90 seconds of drug instillation. If bleeding persisted beyond 90 seconds despite maximal drug administration (up to 3 applications), this was classified as treatment failure and rescue hemostatic measures were initiated.

Secondary outcomes

  1. Rebleeding

    Time frame: Within 30 minutes of initial hemostasis

    Fresh bleeding from the same biopsy site following initial hemostasis, assessed by close clinical observation and repeat inspection with flexible bronchoscopy, with pulse oximetry monitoring to confirm clot stability and adequate ventilation.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Other

Registry information

Official study title

A Comparison Between the Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding - A Randomized Controlled Trial

Acronym: CATER

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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