Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy (CRYOTXA)

Ascension Via Christi Hospitals Wichita, Inc.

Status and phase: Active, not recruiting; Phase 3

Conditions: Endobronchial Mass; Hemorrhage Lung

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06266546

CRYOTXA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

Prophylactic TXA arm

Treatment:

Drug: Tranexamic acid

Control

No Intervention group

Description:

Data collected retrospectively from patients undergoing the same procedure one year prior to the study initiation