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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Prophylactic TXA arm |
|
| Control | No Intervention | Data collected retrospectively from patients undergoing the same procedure one year prior to the study initiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early termination of the procedure due to bleeding | up to 2 hours post procedure | |
| Rate of intermediate hemorrhage | up to 2 hours post procedure | |
| Rate of minor hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Via Christi | Wichita | Kansas | 67214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19246874 | Background | 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. | |
| 31277659 | Background | 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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The study will be a prospective, single-arm, non-randomized trial
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|
| up to 2 hours post procedure |
| Inadequate tissue sampling due to bleeding | y/n | up to 2 hours post procedure |
| 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 |
| Unplanned hospital admission for bleeding complications | hospital readmission | 2 hours post procedure uo to 30 days post procedure |
| Acute cardiovascular side effects | thrombosis events | up to 30 days post procedure |
| All cause 28 day mortality | morality rate | up to 28 days post procedure |
| 28665702 | Background | 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. |
| 31729076 | Background | 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. |
| 27061330 | Background | 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. |
| 28432428 | Background | 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. |
| 23168726 | Background | 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. |
| 32979620 | Background | 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. |