Ascension Via Christi
Wichita, Kansas, 67214, United States
NCT Number: NCT06266546
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Wichita, Kansas, 67214, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 2 hours post procedure
Ordinal scale of less severe to most severe
Time frame: up to 2 hours post procedure
Time frame: up to 2 hours post procedure
Time frame: up to 2 hours post procedure
Time frame: up to 2 hours post procedure
y/n
Time frame: up to 2 hours post procedure
In order of escalating interventions (severity): use of iced saline, epinephrine, mainstem intubation, embolization
Time frame: 2 hours post procedure uo to 30 days post procedure
hospital readmission
Time frame: up to 30 days post procedure
thrombosis events
Time frame: up to 28 days post procedure
morality rate
Youssef Yammine
Other
Acronym: CRYOTXA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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