Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266546
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-01-10
Brief Title:
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Sponsor:
Ascension Via Christi Hospitals Wichita Inc
Organization:
Ascension Via Christi Hospitals Wichita Inc
Study Overview
Official Title:
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYOTXA
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None