Protest Trial: TXA vs Saline

Phase 3

• Conditions: Lung Transplant; Complications Surgical
• Interventions: Other: Saline (placebo); Drug: Tranexamic Acid

• Registration Number: NCT06422273
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

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

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 Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline (placebo)	Topical Saline (placebo) administered as endobronchial topical application.
TXA	Tranexamic Acid	Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients.

Primary Outcome Measures

Name	Time	Method
Bleeding Risk	up to 1 hour	Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States