Protest Trial: TXA vs Saline

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-16

Study Completion Date

2027-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lung Transplant Complications Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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TXA

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

Saline

Topical Saline (placebo) administered as endobronchial topical application.

Group Type PLACEBO_COMPARATOR

Saline (placebo)

Intervention Type OTHER

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

Interventions

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Tranexamic Acid

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

Intervention Type DRUG

Saline (placebo)

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No