Protest Trial: TXA vs Saline

NCT06422273 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: 2024-0552
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Transplant; Complications Surgical

Outcome Measures

Primary Outcomes (1)

• Bleeding Risk

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

  up to 1 hour

Secondary Outcomes (2)

• Procedure time Reduction

  up to 1 hour

• Greater yield in tissue samples

  up to 1 hour

Study Arms (2)

TXA

EXPERIMENTAL

Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients.

Drug: Tranexamic Acid

Saline

PLACEBO COMPARATOR

Topical Saline (placebo) administered as endobronchial topical application.

Other: Saline (placebo)

Interventions

Tranexamic Acid DRUG

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

TXA

Saline (placebo) OTHER

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

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Corewell Health West

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigational pharmacist will be responsible for randomizing on the day of bronchoscopy to placebo or Tranexamic acid in a 1:1 fashion using REDCap software. The pharmacist will be the only individual aware of the randomization assignment. All other study personnel will be blinded to the randomization assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The study design will be a single-center, randomized, double-blinded, placebo-controlled study. The control group will receive topical saline (placebo) and the experimental treatment group will receive topical Tranexamic acid (TXA active drug).

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-01

Locations

US (1)