Clinical trial NCT06422273: Protest Trial: TXA vs Saline
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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Lung Transplant
Complications Surgical
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding Risk
timeFrame: up to 1 hour
Secondary outcomes:
measure: Procedure time Reduction
timeFrame: up to 1 hour
measure: Greater yield in tissue samples
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
Study officials:
References: