Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422273
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-20
First Post:
2024-05-10
Brief Title:
Protest Trial TXA vs Saline
Sponsor:
Spectrum Health Hospitals
Organization:
Spectrum Health Hospitals
Study Overview
Official Title:
Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial Protest Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
None
Brief Summary:
To determine if endobronchial topical tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk
Detailed Description:
Tranexamic acid TXA is an antifibrinolytic agent It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis It also inhibits proteolytic activity of plasmin TXA is frequently used in clinical practice and can be administered via multiple delivery methods including intravenous nebulized and topical It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects It has also been evaluated for prophylactic use with mixed results in reducing bleeding In our current general pulmonary practice topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage
The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies A finding of reduced bleeding would be significant as it could improve clinical outcomes allow for improved diagnostic yield of biopsy samples and improve patient experience It therefore has the potential to change clinical practice and standardize bronchoscopy procedures
The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies A finding of reduced bleeding would be significant as it could improve clinical outcomes allow for improved diagnostic yield of biopsy samples and improve patient experience It therefore has the potential to change clinical practice and standardize bronchoscopy procedures
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?:
None
Is an FDA AA801 Violation?:
None