Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

NCT06266546 · tracked via the Priya Life Science USA tracker

Sponsor

Youssef Yammine

Phase

Phase 3

Started

2024-03-01

Last updated

2026-08-05

Condition(s) studied

Hemorrhage LungEndobronchial Mass

Investigational drug(s) / intervention(s)

Tranexamic acid

Tranexamic acid: Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual.

Study summary

Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥18 * Signed informed consent * Receiving a transbronchial cryobiopsy Exclusion Criteria: * Age below 18 * Pregnancy * Bleeding diathesis (INR \>1.5 or known hematological problems) * Subarachnoid hemorrhage * Any active bleeding (any site) * Decompensated liver disease * Active intravascular clotting * Prior VTE * On oral contraceptive therapy * Platelet count less than 50,000 * Use of antiplatelet medication other than low-dose aspirin within 5 days of procedure * Use of therapeutic anticoagulation within the last 24 hrs * Known severe pulmonary hypertension (pulmonary artery systolic pressure \> 60 mmHg) * Chronic renal failure (estimated GFR below 30 mL/min) * Allergy or hypersensitivity to tranexamic acid or any of its ingredients * Prisoners * Comfort care planned or initiated within 72 hours of admission

Primary outcome measure(s)

Major Hemorrhage — up to 2 hours post procedure
Ordinal scale of less severe to most severe 1\. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage

Trial sites (1)

Facility	City	Region	Status
Ascension Via Christi	Wichita	Kansas

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06266546 on ClinicalTrials.gov ↗ ← All trials in the USA