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Hemorrhage LungPhase 3CRYOTXANCT06266546

Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

A Phase 3 study testing Tranexamic acid in people with Hemorrhage Lung and Endobronchial Mass, run by Youssef Yammine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhage Lung, Endobronchial Mass
What is being tested?
Tranexamic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Mar 2024to 1 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18
  • Signed informed consent
  • Receiving a transbronchial cryobiopsy

Who cannot join

  • Age below 18
  • Pregnancy
  • Bleeding diathesis (INR >1.5 or known hematological problems)
  • Subarachnoid hemorrhage
  • Any active bleeding (any site)
  • Decompensated liver disease
Show all 17Show fewer
  • Active intravascular clotting
  • Prior VTE
  • On oral contraceptive therapy
  • Platelet count less than 50,000
  • Use of antiplatelet medication other than low-dose aspirin within 5 days of procedure
  • Use of therapeutic anticoagulation within the last 24 hrs
  • Known severe pulmonary hypertension (pulmonary artery systolic pressure > 60 mmHg)
  • Chronic renal failure (estimated GFR below 30 mL/min)
  • Allergy or hypersensitivity to tranexamic acid or any of its ingredients
  • Prisoners
  • Comfort care planned or initiated within 72 hours of admission

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ascension Via Christi

    Wichita, Kansas, 67214

Other trials in United States

About this study

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.

Read the detailed description

Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual.

The study will be a prospective, single-arm, non-randomized trial Location: Ascension Via Christi Saint Francis. Medication: Tranexamic acid 500 milligrams per 5 mL ampule (Baxter, NDC 43066-008-01) mixed with 10 mL normal saline.

Patients: A total of 100 patients will be enrolled in the study.

Being tested
Tranexamic acid
Keywords
Transbronchial biopsy, Tranexamic Acid (TXA), Hemorrhage, Prophylaxis
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual.

Study groups in NCT06266546
Study groupRoleWhat they receive
InterventionExperimentalProphylactic TXA arm
Receives: Drug: Tranexamic acid
ControlNo interventionData collected retrospectively from patients undergoing the same procedure one year prior to the study initiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Hemorrhage

    Ordinal scale of less severe to most severe

    1. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage

    Measured: up to 2 hours post procedure

Secondary outcomes (8)

  1. Early termination of the procedure due to bleeding

    Measured: up to 2 hours post procedure

  2. Rate of intermediate hemorrhage

    Measured: up to 2 hours post procedure

  3. Rate of minor hemorrhage

    Measured: up to 2 hours post procedure

  4. Inadequate tissue sampling due to bleeding

    y/n

    Measured: up to 2 hours post procedure

  5. Graded use of other measures to control bleeding (not prophylactic)

    In order of escalating interventions (severity): use of iced saline, epinephrine, mainstem intubation, embolization

    Measured: up to 2 hours post procedure

  6. Unplanned hospital admission for bleeding complications

    hospital readmission

    Measured: 2 hours post procedure uo to 30 days post procedure

  7. Acute cardiovascular side effects

    thrombosis events

    Measured: up to 30 days post procedure

  8. All cause 28 day mortality

    morality rate

    Measured: up to 28 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Model description
The study will be a prospective, single-arm, non-randomized trial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06266546
Sponsor's protocol ID
RKS20230026
Acronym
CRYOTXA
Status last verified
Aug 2026
First submitted
10 Jan 2024
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.

    PubMed 19246874

  • Hetzel J, Eberhardt R, Petermann C, Gesierich W, Darwiche K, Hagmeyer L, Muche R, Kreuter M, Lewis R, Ehab A, Boeckeler M, Haentschel M. Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial. Respir Res. 2019 Jul 5;20(1):140. doi: 10.1186/s12931-019-1091-1.

    PubMed 31277659

  • Bendstrup E, Kronborg-White S, Poletti V, Folkersen B, Voldby N, Rasmussen TR. Careful Planning Reduces Cryobiopsy Complications. Ann Am Thorac Soc. 2017 Jul;14(7):1229. doi: 10.1513/AnnalsATS.201703-196LE. No abstract available.

    PubMed 28665702

  • Cai J, Ribkoff J, Olson S, Raghunathan V, Al-Samkari H, DeLoughery TG, Shatzel JJ. The many roles of tranexamic acid: An overview of the clinical indications for TXA in medical and surgical patients. Eur J Haematol. 2020 Feb;104(2):79-87. doi: 10.1111/ejh.13348. Epub 2019 Dec 16.

    PubMed 31729076

  • Zhou GW, Zhang W, Dong YC, Huang HD, Hu C, Sun J, Jin F, Gu Y, Li Q, Li S. Flexible bronchoscopy-induced massive bleeding: A 12-year multicentre retrospective cohort study. Respirology. 2016 Jul;21(5):927-31. doi: 10.1111/resp.12784. Epub 2016 Apr 8.

    PubMed 27061330

  • Pabinger I, Fries D, Schochl H, Streif W, Toller W. Tranexamic acid for treatment and prophylaxis of bleeding and hyperfibrinolysis. Wien Klin Wochenschr. 2017 May;129(9-10):303-316. doi: 10.1007/s00508-017-1194-y. Epub 2017 Apr 21.

    PubMed 28432428

  • Marquez-Martin E, Vergara DG, Martin-Juan J, Flacon AR, Lopez-Campos JL, Rodriguez-Panadero F. Endobronchial administration of tranexamic Acid for controlling pulmonary bleeding: a pilot study. J Bronchology Interv Pulmonol. 2010 Apr;17(2):122-5. doi: 10.1097/LBR.0b013e3181dc8c17.

    PubMed 23168726

  • Kuint R, Levy L, Cohen Goichman P, Huszti E, Abu Rmeileh A, Shriki O, Abutbul A, Fridlender ZG, Berkman N. Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial. Respir Med. 2020 Nov;173:106162. doi: 10.1016/j.rmed.2020.106162. Epub 2020 Sep 21.

    PubMed 32979620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic acid in people with Hemorrhage Lung and Endobronchial Mass, run by Youssef Yammine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Hemorrhage (time frame: up to 2 hours post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06266546, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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