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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+