Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618820
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Extended Oral Tranexamic Acid After Total Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The utilization of intraoperative tranexamic acid TXA whether administered intravenously or orally has become a standard practice in total joint arthroplasty TJA Multiple studies have demonstrated the positive impact that TXA application has on clinical outcomes including decreased blood loss and transfusion rates decreased early swelling and ecchymosis improved early recovery and potentially superior long-term outcomes Its ability to mitigate risk of blood loss made ambulatory total knee arthroplasty TKA safer for patients The safety of intraoperative TXA use has also been documented Sabbag et al showed that TXA does not increase the risk of venous thromboembolism VTE even in those patients who are deemed high-risk Multiple routes of TXA administration have been studied with each route demonstrating effectiveness in reducing blood loss Findings showed that oral TXA is noninferior to intravenous TXA though the median time to reach a target concentration is longer via the oral route and bioavailability is lower With the benefits of intraoperative TXA clearly documented in literature multiple centers investigated the utilization of extended TXA postoperatively in hopes of enhancing patient safety and reducing length of stay and healthcare cost However these studies reported conflicting outcomes and mostly focused on estimated blood loss instead of patient reported outcomes
The purpose of this study is to assess the effectiveness and safety of a varying extended oral TXA regimen during the postoperative period Further the investigators aim to determine the optimal duration of the TXA regimen to maximize its impact The investigators hypothesize that an extended oral TXA regimen is safe and effective in improving clinical outcomes in TKA patients
The purpose of this study is to assess the effectiveness and safety of a varying extended oral TXA regimen during the postoperative period Further the investigators aim to determine the optimal duration of the TXA regimen to maximize its impact The investigators hypothesize that an extended oral TXA regimen is safe and effective in improving clinical outcomes in TKA patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None