Clinical trial NCT06266546: Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Official title: Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hemorrhage Lung
Endobronchial Mass
Keywords: Transbronchial biopsy
Tranexamic Acid (TXA)
Hemorrhage
Prophylaxis
Lead sponsor: Ascension Via Christi Hospitals Wichita, Inc.
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study will be a prospective, single-arm, non-randomized trial
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Hemorrhage
timeFrame: up to 2 hours post procedure
Secondary outcomes:
measure: Early termination of the procedure due to bleeding
timeFrame: up to 2 hours post procedure
measure: Rate of intermediate hemorrhage
timeFrame: up to 2 hours post procedure
measure: Rate of minor hemorrhage
timeFrame: up to 2 hours post procedure
measure: Inadequate tissue sampling due to bleeding
timeFrame: up to 2 hours post procedure
measure: Graded use of other measures to control bleeding (not prophylactic)
timeFrame: up to 2 hours post procedure
measure: Unplanned hospital admission for bleeding complications
timeFrame: 2 hours post procedure uo to 30 days post procedure
measure: Acute cardiovascular side effects
timeFrame: up to 30 days post procedure
measure: All cause 28 day mortality
timeFrame: up to 28 days post procedure
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Ascension Via Christi
state: Kansas
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.