The Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding

NCT07759089 | Completed

• 2 other identifiers: MahmudTNo funding
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Endobronchial Bleeding; Hemoptysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Immediate Hemostasis (Bleeding Cessation)

  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.

  Within 90 seconds of drug instillation

Secondary Outcomes (1)

• Rebleeding

  Within 30 minutes of initial hemostasis

Study Arms (2)

Adrenaline Group

ACTIVE COMPARATOR

Patients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; concentration 0.05 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted.

Drug: Adrenaline

Tranexamic Acid Group

EXPERIMENTAL

Patients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; concentration 25 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted.

Drug: Tranexamic Acid

Interventions

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.

Adrenaline Group

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.

Tranexamic Acid Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead

Study Sites (1)

Sheikh Zayed Hospital

Lahore, Punjab Province, 54470, Pakistan

Location

MeSH Terms

Conditions

Hemoptysis

Interventions

Epinephrine; Tranexamic Acid

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Talha Mahmud

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 11, 2026
• Study Start: January 3, 2022
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

PA (1)