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

A

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)

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

Trial contacts and locations

1

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Central trial contact

Youssef Yammine, MD

Data sourced from clinicaltrials.gov

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