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Enrolling by Invitation

NCT Number: NCT06422273

Protest Trial: TXA vs Saline

To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Corewell Health West

Grand Rapids, Michigan, 49503, United States

About this study

Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practice, topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage.

The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. A finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. It therefore has the potential to change clinical practice and standardize bronchoscopy procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Single or double lung transplant recipients
  • Patients >18 years old
  • Willingness and ability to sign an informed consent for study participation

Exclusion criteria

  • Platelet count (<50k/uL)
  • INR (>1.6)
  • Active bleeding
  • Decompensated liver disease
  • History of uremic bleeding or BUN >50
  • Severe pulmonary hypertension (mean PA pressure >40 mmHg on RHC or estimated PA systolic pressure >62 mmHg on TTE within one year of procedure)
  • Known bleeding disorder
  • Allergy to TXA
  • Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention)
  • Contraindications to topical TXA
  • Pregnancy
  • Vulnerable populations
  • Adults of limited English proficiency/non-English speakers

Treatment and study plan

Tranexamic Acid

Drug

Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients

Saline (Placebo)

Other

Topical Saline (placebo) administered as endobronchial topical application prior to performing transbronchial biopsies in lung transplant recipients.

Primary outcomes

  1. Bleeding Risk

    Time frame: up to 1 hour

    Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive

Secondary outcomes

  1. Procedure time Reduction

    Time frame: up to 1 hour

    Procedure times will be recorded for both the tranexamic acid and the control saline group.

  2. Greater yield in tissue samples

    Time frame: up to 1 hour

    This will be measured by the number of pieces of tissue from the pathology report

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial (Protest Trial)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 20, 2024
Registry last updated
Jul 21, 2026

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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