Protest Trial: TXA vs Saline

Lung Transplant; Complications Clinical Trial

Official 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06422273
• Other study ID #: 2024-0552
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 16, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant; Complications

Intervention

Drug:
• Tranexamic Acid
Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients

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

Locations

Country	Name	City	State
United States	Spectrum Health Hospitals	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Risk	Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive	up to 1 hour
Secondary	Procedure time Reduction	Procedure times will be recorded for both the tranexamic acid and the control saline group.	up to 1 hour
Secondary	Greater yield in tissue samples	This will be measured by the number of pieces of tissue from the pathology report	up to 1 hour