Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428682
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-20
Brief Title:
Role of TXA in Patients Undergoing Breast Free Flap Reconstruction
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Tranexamic acid TXA is a synthetic competitive lysine receptor inhibitor on plasminogen It ultimately stabilizes the fibrin matrix therefore used as a hemostatic agent for various indications While there has been indications for orthopedic and trauma surgery there is no clear data for its role in patients who are undergoing free tissue transfer Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 72 to 349 which data also showing association between transfusion requirement and higher free flap failure rate There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized prospective trial Control group will not receive TXA while experimental group will receive TXA Both groups will receive standard of care breast free flap surgery as well as post-op care which is streamlined with Early Recovery After Surgery ERAS protocol Their pre and post-op hemoglobin will be compared as well as rates of transfusion surgical outcome and surgical complications including hematoma flap failure and any other medical complications such as Deep Vein Thrombosis DVT Pulmonary Embolism PE
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None