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

94 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the drug Tranexamic Acid for lung transplant complications?

Research shows that Tranexamic Acid (TXA) is effective in reducing blood loss and the need for blood transfusions in surgeries like knee replacements, which suggests it might help manage bleeding in lung transplants as well. ^{1 2 3 4 5}

Is tranexamic acid generally safe for use in humans?

Tranexamic acid (TXA) is generally considered safe for use in humans, as it has been shown to reduce blood loss and the need for blood transfusions in various surgeries without increasing the risk of death or vascular problems. However, it may increase the risk of seizures in cardiac surgery. ^{3 6 7 8 9}

How is the drug Tranexamic Acid unique for lung transplant complications?

Tranexamic Acid (TXA) is unique because it helps reduce bleeding by stabilizing blood clots, which can be particularly beneficial in managing complications like hemoptysis (coughing up blood) in lung-related conditions. Unlike other treatments, TXA can be administered in various ways, including noninvasive methods like nebulization, making it a versatile option for patients who may not tolerate invasive procedures. ^{4 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical Tranexamic Acid May Improve Early Functional Outcomes of Primary Total Knee Arthroplasty. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Different Doses of Intravenous Tranexamic Acid in Revision Total Knee Arthroplasty: A Retrospective Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of tranexamic acid in bilateral total knee arthroplasty: A meta-analysis. [2018]

4. France pubmed.ncbi.nlm.nih.gov

[Tranexamic acid reduces haematomas but not pain after total knee arthroplasty]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Preliminary results suggest tranexamic acid is safe and effective in arthroplasty patients with severe comorbidities. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of tranexamic acid on short-term and long-term outcomes of on-pump coronary artery bypass grafting: Randomized trial and 7-year follow-up. [2019]

7. Switzerland 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. [2022]

8. England 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Role of Tranexamic Acid in the Clinical Setting. [2020]

10. China 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of recurrent hemoptysis in a child with cystic fibrosis by repeated bronchial artery embolizations and long-term tranexamic acid. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Nebulized Tranexamic Acid as a Noninvasive Therapy for Cancer-Related Hemoptysis. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

Effect of Tranexamic Acid on Wound Complications and Blood Loss in Total Ankle Arthroplasty. [2022]