Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

Endobronchial Mass Clinical Trial

— CRYOTXA  

Official title:

Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06266546
• Other study ID #: CRYOTXA
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Ascension Via Christi Hospitals Wichita, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18

• Signed informed consent

• Receiving a transbronchial cryobiopsy

Exclusion Criteria:

• Age below 18

• Pregnancy

• Bleeding diathesis (INR >1.5 or known hematological problems)

• Subarachnoid hemorrhage

• Any active bleeding (any site)

• Decompensated liver disease

• 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

Related Conditions & MeSH terms

• Endobronchial Mass
• Hemorrhage

Intervention

Drug:
• Tranexamic acid
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.

Locations

Country	Name	City	State
United States	Ascension Via Christi	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Ascension Via Christi Hospitals Wichita, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Hemorrhage	Ordinal scale of less severe to most severe; 1. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage	up to 2 hours post procedure
Secondary	Early termination of the procedure due to bleeding		up to 2 hours post procedure
Secondary	Rate of intermediate hemorrhage		up to 2 hours post procedure
Secondary	Rate of minor hemorrhage		up to 2 hours post procedure
Secondary	Inadequate tissue sampling due to bleeding	y/n	up to 2 hours post procedure
Secondary	Graded use of other measures to control bleeding (not prophylactic)	In order of escalating interventions (severity): use of iced saline, epinephrine, mainstem intubation, embolization	up to 2 hours post procedure
Secondary	Unplanned hospital admission for bleeding complications	hospital readmission	2 hours post procedure uo to 30 days post procedure
Secondary	Acute cardiovascular side effects	thrombosis events	up to 30 days post procedure
Secondary	All cause 28 day mortality	morality rate	up to 28 days post procedure