Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

Phase 3Active Not RecruitingNCT06266546

Youssef Yammine100 enrolled

Overview

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.

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. The study will be a prospective, single-arm, non-randomized trial Location: Ascension Via Christi Saint Francis. Medication: Tranexamic acid 500 milligrams per 5 mL ampule (Baxter, NDC 43066-008-01) mixed with 10 mL normal saline. Patients: A total of 100 patients will be enrolled in the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Hemorrhage Lung Endobronchial Mass

Interventions

Tranexamic acidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ascension Via Christi

Wichita, Kansas, United States

Outcomes

Primary Outcomes

Major Hemorrhage

Ordinal scale of less severe to most severe 1\. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage