Protest Trial: TXA vs Saline

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Drug: Tranexamic Acid; Other: Saline (placebo)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXA; Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients.	Drug: Tranexamic Acid; Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients
Placebo Comparator: Saline; Topical Saline (placebo) administered as endobronchial topical application.	Other: Saline (placebo); Topical Saline (placebo) administered as endobronchial topical application prior to performing transbronchial biopsies in lung transplant recipients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Risk	Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time Reduction	Procedure times will be recorded for both the tranexamic acid and the control saline group.	up to 1 hour
Greater yield in tissue samples	This will be measured by the number of pieces of tissue from the pathology report	up to 1 hour

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2024-0552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No