Tranexamic Acid for Reducing Biopsy Bleeding

(CRYOTXA Trial)

Overseen By Youssef Yammine, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ascension Via Christi Hospitals Wichita, Inc.

Must not be taking: Antiplatelets, Anticoagulants, Oral contraceptives

Disqualifiers: Pregnancy, Liver disease, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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 6 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 tests whether tranexamic acid, a medication used to reduce bleeding, can help minimize bleeding during transbronchial cryobiopsy, a procedure for taking tissue samples from the airways. Although generally safe, this procedure carries a risk of bleeding at the biopsy site. The trial aims to determine if tranexamic acid can enhance safety. Participants are divided into two groups: one receives tranexamic acid before the procedure, while the other examines past data from individuals who underwent the procedure without it. This trial may suit adults scheduled for a transbronchial cryobiopsy. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially safer medical procedures.

Will I have to stop taking my current medications?

The trial requires that you stop taking antiplatelet medications (except low-dose aspirin) within 5 days of the procedure and therapeutic anticoagulation within the last 24 hours. If you are on these medications, you may need to stop them before participating.

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

Research shows that tranexamic acid is generally safe for people. Past studies have demonstrated its effectiveness in reducing bleeding. For instance, it treats heavy menstrual bleeding, reducing it by 26% to 60%, which helps manage blood loss effectively.

When applied directly to an area, as in this study, tranexamic acid poses a very low risk of causing systemic side effects. It primarily works at the application site without causing problems elsewhere.

Overall, tranexamic acid is well-tolerated, especially when used in specific areas to control bleeding. The phase of this trial indicates strong evidence already exists regarding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tranexamic acid is unique because it specifically targets bleeding by helping blood to clot more effectively. Unlike other treatments for biopsy bleeding, which might rely on pressure or cauterization to stop bleeding, tranexamic acid acts by stabilizing blood clots. This makes it a promising option for reducing bleeding risks during biopsies. Researchers are excited about tranexamic acid because it has the potential to provide a more reliable and less invasive way to manage bleeding, making procedures safer for patients.

What evidence suggests that tranexamic acid is effective for reducing biopsy bleeding?

Research has shown that tranexamic acid helps reduce bleeding. In studies on heavy menstrual bleeding, it reduced blood loss by 26% to 60%. It also lessened bleeding during surgeries, such as breast surgery, by decreasing the blood collected in drains and shortening the time those drains are needed. In this trial, participants in the intervention arm will receive tranexamic acid to evaluate its potential in reducing bleeding risks during transbronchial cryobiopsies. These findings suggest that tranexamic acid can help control bleeding in various medical situations. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over the age of 18 who are scheduled to undergo a transbronchial cryobiopsy, which is a procedure to take tissue samples from the airways. Participants must be able to give informed consent.

Inclusion Criteria

Signed informed consent

I am undergoing a special lung biopsy procedure.

Exclusion Criteria

I am under 18 years old.

Pregnancy

Platelet count less than 50,000

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Prophylactic tranexamic acid is administered endobronchially one minute prior to transbronchial cryobiopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of bleeding and cardiovascular side effects

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid

Trial Overview The study is testing whether giving tranexamic acid before a transbronchial cryobiopsy can reduce bleeding risks associated with this diagnostic procedure.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Prophylactic TXA arm

Group II: Control Active Control 1 Intervention

Data collected retrospectively from patients undergoing the same procedure one year prior to the study initiation

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

Approved in United States as Lysteda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma

Approved in European Union as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Approved in Japan as Nicolda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Who Is Running the Clinical Trial?

Ascension Via Christi Hospitals Wichita, Inc.

Lead Sponsor

Trials

5

Recruited

170+

Youssef Yammine

Lead Sponsor

Trials

1

Recruited

100+

Abdel-Ghanie H. Abu-Samra, MD

Collaborator

Trials

1

Recruited

100+

Patrick Evans, PharmD, BCPS

Collaborator

Trials

1

Recruited

100+

Youssef Yammine, MD

Collaborator

Trials

1

Recruited

100+

Elio Junior Feghali, MD

Collaborator

Trials

1

Recruited

100+

Erica N Krantz, PharmD, BCCCP

Collaborator

Trials

1

Recruited

100+

Abdul Rahman Akkawi, MD

Collaborator

Trials

1

Recruited

100+

Craig Beavers, DO

Collaborator

Trials

1

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3430088/

Tranexamic acid for the treatment of heavy menstrual ... Tranexamic acid has proven to be an effective treatment for heavy menstrual bleeding (HMB). It reduces menstrual blood loss (MBL) by 26%–60%.

2. stacks.cdc.gov stacks.cdc.gov/view/cdc/214405/cdc_214405_DS1.pdf

Tranexamic Acid Treatment for Heavy Menstrual Bleeding The prespecified three-component primary effi- cacy end point was mean reduction in menstrual blood loss with tranexamic acid treatment that was 1).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02615366

Tranexamic Acid for Bleeding in Breast Surgery The aim of this study is to determine if TXA is superior to placebo in reducing the bleeding complications in breast surgeries.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526820925000205

Tranexamic Acid in Breast Surgery – A Systematic Review ... Both topical and intravenous TXA in breast surgery significantly reduce hematoma and reduce drain output and time upon drain removal.

5. researchgate.net researchgate.net/publication/379097350_Tranexamic_Acid_for_Management_of_Heavy_Vaginal_Bleeding_Barriers_to_Access_and_Myths_Surrounding_Its_Use

Tranexamic Acid for Management of Heavy Vaginal Bleeding Tranexamic acid is safe and effective for the treatment of heavy vaginal bleeding during menstruation and childbirth.

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

Prophylactic use of tranexamic acid for prevention of ... Reducing biopsy related airway bleeding may increase the yield and improve the safety of the procedure. Data regarding the use of TXA in the setup of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8860217/

Safety and Efficacy of Local Tranexamic Acid for the ... Local use of tranexamic acid may reduce blood loss comparably to intravenous prophylactic use with negligible risk of systemic adverse effects.

8. go.drugbank.com go.drugbank.com/drugs/DB00302

Tranexamic acid: Uses, Interactions, Mechanism of Action Tranexamic acid is an antifibrinolytic used to reduce or prevent hemorrhagic episodes, especially in the context of hyperfibrinolytic disorders.

9. mayoclinic.org mayoclinic.org/drugs-supplements/tranexamic-acid-oral-route/description/drg-20073517

Tranexamic acid (oral route) - Side effects & dosage It works by blocking the breakdown of blood clots, which prevents bleeding. This medicine is available only with your doctor's prescription.