Tranexamic Acid for Lung Transplant Complications

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Spectrum Health Hospitals

Disqualifiers: Bleeding disorder, Liver disease, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tranexamic acid, applied directly to the lungs, can reduce bleeding in individuals who have had a lung transplant and need a biopsy. The researchers compare tranexamic acid to a placebo (inactive treatment) to assess its impact on bleeding risk. The trial seeks individuals who have received a lung transplant and are undergoing a transbronchial biopsy, provided they do not have conditions like severe liver disease or known bleeding disorders. Participants must also be able to give informed consent. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?

Research has shown that tranexamic acid is generally safe for people. Studies have found that using tranexamic acid in lung transplant patients before biopsies reduces bleeding without causing additional side effects. For instance, in some studies, patients who received tranexamic acid bled less than those who received a placebo and did not experience negative reactions.

However, while tranexamic acid did not lead to more deaths or serious issues in these studies, it has been associated with a risk of seizures in heart surgery patients. This risk was specific to heart surgery and may not apply to lung procedures. Overall, evidence suggests that tranexamic acid is well-tolerated in lung transplants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about tranexamic acid for lung transplant complications because it offers a novel approach to reducing bleeding risks associated with transbronchial biopsies. Unlike standard treatments that focus on managing bleeding after it starts, tranexamic acid acts prophylactically by stabilizing blood clots and preventing excessive bleeding before it happens. This proactive strategy could significantly improve patient safety and outcomes during lung transplant procedures.

What evidence suggests that tranexamic acid is effective for reducing bleeding risk in lung transplant recipients?

In this trial, participants will receive either tranexamic acid (TXA) or a saline placebo. Studies have shown that TXA effectively reduces the risk of bleeding in lung transplant patients. When administered before a transbronchial biopsy, TXA lessens bleeding. Research indicates that patients who received TXA experienced less bleeding and could undergo more biopsies without additional side effects. This suggests that TXA could serve as a helpful preventative treatment for bleeding complications during biopsies in lung transplant patients. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for lung transplant recipients over 18 who can consent to participate. It's not for those with TXA allergies, liver disease, bleeding disorders, severe past bleeding after lung biopsies, non-English speakers, low platelets or abnormal clotting tests (INR >1.6), active bleeding, certain kidney issues (BUN >50), pregnant women or vulnerable groups.

Inclusion Criteria

I am willing and able to sign a consent form for the study.

I have had a lung transplant.

I am over 18 years old.

Exclusion Criteria

Allergy to TXA

My liver is not working properly.

I have a known bleeding disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tranexamic acid or saline prior to transbronchial biopsies to assess bleeding risk

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study is testing if using tranexamic acid (TXA) on the airways before taking lung tissue samples in transplant patients reduces the risk of bleeding compared to a saline placebo. Participants are randomly assigned to receive either TXA or saline.

How Is the Trial Designed?

Group I: TXA Experimental Treatment 1 Intervention

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

Group II: Saline Placebo Group 1 Intervention

Topical Saline (placebo) administered as endobronchial topical application.

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Published Research Related to This Trial

A case study demonstrated that nebulized tranexamic acid (TXA) effectively resolved significant hemoptysis in a patient with an invasive airway malignancy within 15 minutes, indicating its rapid action.

The use of nebulized TXA appears to be a safe and noninvasive option for managing hemoptysis, suggesting its potential as a palliative treatment for patients experiencing chronic or acute bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized Tranexamic Acid as a Noninvasive Therapy for Cancer-Related Hemoptysis. Hankerson, MJ., Raffetto, B., Mallon, WK., et al.[2015]

Intravenous tranexamic acid (TXA) significantly reduces the need for reoperation due to bleeding, the frequency of blood transfusions, and postoperative chest tube drainage in patients undergoing coronary artery bypass grafting (CABG), based on a meta-analysis of 28 studies.

While TXA does not increase the risk of major complications like mortality or myocardial infarction, it may raise the risk of postoperative seizures, indicating a need for careful monitoring when used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficiency of intravenous administration of tranexamic acid in coronary artery bypass grafting (CABG): a meta-analysis of 28 randomized controlled trials. Zhang, Y., Bai, Y., Chen, M., et al.[2020]

Tranexamic acid (TXA) is effective in reducing blood loss and the need for blood transfusions across various types of surgeries, including orthopedic and cardiac procedures, based on a systematic review of 47 meta-analyses involving numerous outcomes.

TXA is generally safe, showing no increase in death or vascular adverse events, although it may pose a risk for seizures in cardiac surgery, highlighting the need for tailored dosing recommendations for different surgical types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Tranexamic Acid Reduce the Blood Loss in Various Surgeries? An Umbrella Review of State-of-the-Art Meta-Analysis. Hong, P., Liu, R., Rai, S., et al.[2022]

Tranexamic acid (TxA) significantly reduces the volume of hematomas after total knee arthroplasty (TKA), with a decrease from 526 mL in the control group to 337 mL in the TxA group, indicating its efficacy in minimizing blood loss.

Despite the reduction in hematoma volume, TxA did not lead to a significant decrease in morphine consumption for pain management or improve rehabilitation outcomes within the first six months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tranexamic acid reduces haematomas but not pain after total knee arthroplasty]. Chevet, I., Remérand, F., Couvret, C., et al.[2013]

A meta-analysis of 28 randomized controlled trials involving 4,200 participants found that combined administration of tranexamic acid (TXA) significantly reduces total blood loss and postoperative hemoglobin drop compared to using TXA through a single route (oral, intravenous, or topical).

Oral administration of TXA showed similar efficacy to intravenous or topical routes, indicating that it can be an effective alternative for reducing blood loss in total knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the ideal route of administration of tranexamic acid in total knee arthroplasty? A meta-analysis based on randomized controlled trials. Lu, F., Sun, X., Wang, W., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-3-lung-transplant-complications-3-2024-5e02c

Tranexamic Acid for Lung Transplant Complications What data supports the effectiveness of the drug Tranexamic Acid for lung transplant complications? Research shows that Tranexamic Acid (TXA) is effective ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/73/NCT06422273/Prot_SAP_000.pdf

STUDY PROTOCOL The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11595684/

Transition from Transbronchial Forceps to Cryobiopsy After ... The complication rate did not increase significantly in CBs vs. FBs. Keywords: lung transplantation, acute cellular rejection, chronic rejection ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0954611120303024

Prophylactic use of tranexamic acid for prevention of ... Endobronchial installation of TXA prior to obtaining TBLB results in less bleeding and allows more biopsies to be obtained with no additional adverse events.

5. jhltonline.org jhltonline.org/article/S1053-2498(23)01786-2/abstract

Prophylactic epinephrine attenuates severe bleeding in ... The primary outcome of severe or very severe hemorrhage occurred in 4 cases (8%) in the prophylactic epinephrine group and in 13 cases (24%) in ...