Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479161
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-20
Brief Title:
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
Sponsor:
Matthew Grosso MD
Organization:
Trinity Health Of New England
Study Overview
Official Title:
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion A Randomized Control 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:
The primary purpose of this study is to evaluate postoperative pain Secondary outcomes evaluated in this study will include range of motion ROM opioid consumption and ambulation Each outcome measure will be evaluated oral tranexamic acid TXA in the experiment arm and placebo in the control arm after total knee arthroplasty TKA at postoperative days 0-3 and weeks 1 2 6 and 12
Detailed Description:
Randomized controlled trial with 11 allocation selected through computer-based randomization
This study will review prospectively collected data including patient demographic information surgeon use of oral TXA or placebo regimen and postoperative outcomes up to 3 months after surgery Collaboration with Saint Francis pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication
This will be a double blinded study with both patient and surgeon blinded to study group
60 TXA dosing protocol TXA day of surgery All patients
Administer 1-gram IV TXA intraoperatively at the start of the case hold for history of stent within 1 year of surgery
o AND
Administer 1-gram IV TXA postoperatively before leaving PACU hold for history of stent within 1 year of surgery
o OR
Exception Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery
TXA postoperative day POD 1-3 Experimental group
Administer 195 grams oral 3- 650 mg tablets TXA each morning for three days following surgery
Patients discharged home before POD 3 will be sent home with remaining oral TXA doses
Placebo POD 1-3 Control group
Administer oral placebo 3 tablets each morning for three days following surgery
Patients discharged home before POD 3 will be sent home with remaining oral placebo doses
This study will review prospectively collected data including patient demographic information surgeon use of oral TXA or placebo regimen and postoperative outcomes up to 3 months after surgery Collaboration with Saint Francis pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication
This will be a double blinded study with both patient and surgeon blinded to study group
60 TXA dosing protocol TXA day of surgery All patients
Administer 1-gram IV TXA intraoperatively at the start of the case hold for history of stent within 1 year of surgery
o AND
Administer 1-gram IV TXA postoperatively before leaving PACU hold for history of stent within 1 year of surgery
o OR
Exception Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery
TXA postoperative day POD 1-3 Experimental group
Administer 195 grams oral 3- 650 mg tablets TXA each morning for three days following surgery
Patients discharged home before POD 3 will be sent home with remaining oral TXA doses
Placebo POD 1-3 Control group
Administer oral placebo 3 tablets each morning for three days following surgery
Patients discharged home before POD 3 will be sent home with remaining oral placebo doses
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