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NCT Number: NCT06266546

Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ascension Via Christi

Wichita, Kansas, 67214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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.

Primary outcomes

  1. Major Hemorrhage

    Time frame: up to 2 hours post procedure

    Ordinal scale of less severe to most severe

    • No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage

Secondary outcomes

  1. Early termination of the procedure due to bleeding

    Time frame: up to 2 hours post procedure

  2. Rate of intermediate hemorrhage

    Time frame: up to 2 hours post procedure

  3. Rate of minor hemorrhage

    Time frame: up to 2 hours post procedure

  4. Inadequate tissue sampling due to bleeding

    Time frame: up to 2 hours post procedure

    y/n

  5. Graded use of other measures to control bleeding (not prophylactic)

    Time frame: up to 2 hours post procedure

    In order of escalating interventions (severity): use of iced saline, epinephrine, mainstem intubation, embolization

  6. Unplanned hospital admission for bleeding complications

    Time frame: 2 hours post procedure uo to 30 days post procedure

    hospital readmission

  7. Acute cardiovascular side effects

    Time frame: up to 30 days post procedure

    thrombosis events

  8. All cause 28 day mortality

    Time frame: up to 28 days post procedure

    morality rate

Sponsors and collaborators

Lead sponsor

Youssef Yammine

Other

Registry information

Acronym: CRYOTXA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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