CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 enrolled
Drug / intervention
Tranexamic Acid standard dose +3 moredrug
Likely dose
Females Tranexamic Acid weighted dose 20mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01651806
NCT01651806Phase 3Completed
CompareCT.gov

Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.

Rush University Medical Center·interventional·Posted Jul 27, 2012·Updated Dec 13, 2017

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid standard dose, Females Tranexamic Acid weighted dose, and 2 other interventions for Osteoarthritis and Intraoperative Bleeding. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Intraoperative Bleeding
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2012
Enrollment StartMay 1, 2012
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.9 years ago

Interventions

Tranexamic Acid standard dosedrug

Uniform 1 gram dosing

Females Tranexamic Acid weighted dosedrug

Weighted dose--20mg/kg of the drug will be given

Females receiving a uniform dose of TAdrug

Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.

Males Weighted Dose TAdrug

Weighted dose--20mg/kg of the drug will be given