Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 12:52 AM
Study NCT ID:
NCT01651806
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2012-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.
Status:
COMPLETED
Status Verified Date:
2017-12
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:
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.
Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
Detailed Description:
Overall Study Design
Study design and control methods:
This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).
Treatment group:
The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.
Treatment allocation:
All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.
Trial Population
Target population:
The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.
Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.
Study design and control methods:
This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).
Treatment group:
The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.
Treatment allocation:
All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.
Trial Population
Target population:
The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.
Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.
Study Oversight
Has Oversight DMC:
True
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?: