## Protocol Section
### Identification Module
**NCT ID:** NCT06422273

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 2024-0552
#### Organization
**Class:** OTHER
**Full Name:** Spectrum Health Hospitals
### Status Module
#### Completion Date
**Date:** 2026-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Spectrum Health Hospitals

#### Responsible Party

**Investigator Affiliation:** Spectrum Health Hospitals

**Investigator Full Name:** Sheila Krishnan

**Investigator Title:** Principle Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Lung Transplant; Complications

### Design Module

#### Design Info

**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).

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** 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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 94

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Tranexamic Acid

**Label:** TXA

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Topical Saline (placebo) administered as endobronchial topical application.

**Intervention Names:**

- Other: Saline (placebo)

**Label:** Saline

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TXA

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

**Name:** Tranexamic Acid

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Saline

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

**Name:** Saline (placebo)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive

**Measure:** Bleeding Risk

**Time Frame:** up to 1 hour

#### Secondary Outcomes

**Description:** Procedure times will be recorded for both the tranexamic acid and the control saline group.

**Measure:** Procedure time Reduction

**Time Frame:** up to 1 hour

**Description:** This will be measured by the number of pieces of tissue from the pathology report

**Measure:** Greater yield in tissue samples

**Time Frame:** up to 1 hour

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Spectrum Health Hospitals

**State:** Michigan

**Zip:** 49503

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-02-20

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 375346

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-16T12:12

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000933

- Term: Antifibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006490

- Term: Hemostatics

- ID: D000003029

- Term: Coagulants

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16902

- Name: Tranexamic Acid

- Relevance: HIGH

- As Found: Stage IV

- ID: M4252

- Name: Antifibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014148

- Term: Tranexamic Acid

### Misc Info Module

- Version Holder: 2024-05-31
