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The Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07759089
Acronym
CATER
Enrollment
76
Registered
2026-08-11
Start date
2022-01-03
Completion date
2023-01-02
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endobronchial Bleeding, Hemoptysis

Keywords

ranexamic acid, adrenaline, Endobronchial bleeding, Bronchoscopy, endobronchial biopsy, Hemostasis

Brief summary

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.

Detailed description

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.

Interventions

DRUGAdrenaline

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.

DRUGTranexamic Acid

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.

Sponsors

Sheikh Zayed Federal Postgraduate Medical Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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: 1. Cardiac arrhythmias 2. Oxygen saturation below 90% on supplemental oxygen 3. Acute respiratory failure with hypercapnia 4. 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

Design outcomes

Primary

MeasureTime frameDescription
Immediate Hemostasis (Bleeding Cessation)Within 90 seconds of drug instillationImmediate 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

MeasureTime frameDescription
RebleedingWithin 30 minutes of initial hemostasisFresh 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026