Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919615
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-04-24
Brief Title:
Use of Tranexamic Acid in the Total Knee Arthroplasty
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation of Efficacy and Safety of Perioperative Tranexamic Acid During Primary Total Knee Arthroplasty A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-06
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 is a medication used to treat or prevent excessive blood loss during surgery Previous studies have shown tranexamic acid TXA reduces blood loss and post-operative blood transfusion rate without significant complications In addition many meta-analyses have confirmed these results This study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty
Detailed Description:
Tranexamic acid TXA is used to control both intraoperative IO and postoperative PO bleeding during various surgical procedures Moreover TXA was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients This study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty The study is a prospective randomized triple-blinded placebo-controlled study Ninety participants were enrolled between July 2021 and September 2022 and followed up with every patient for six months
The study was done in Damascus Syria Participants were randomly assigned following simple randomization procedures computerized random numbers to 1 of 2 groups The allocation was put into concealed envelopes independent of the surgeon and the author and the randomization was performed by a research fellow who was not involved in patient care Participants who went unilateral primary TKA and did not use TXA just IV normal saline 09 sodium chloride formed the control group In contrast the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows 10mgkg of Tranexamic Acid in 100 Millilitersml normal saline 09 sodium chloride the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage
The study was done in Damascus Syria Participants were randomly assigned following simple randomization procedures computerized random numbers to 1 of 2 groups The allocation was put into concealed envelopes independent of the surgeon and the author and the randomization was performed by a research fellow who was not involved in patient care Participants who went unilateral primary TKA and did not use TXA just IV normal saline 09 sodium chloride formed the control group In contrast the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows 10mgkg of Tranexamic Acid in 100 Millilitersml normal saline 09 sodium chloride the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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