CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 246 enrolled
Drug / intervention
Amicar +1 moredrug
Likely dose
Not stated in 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/NCT02030821
NCT02030821Phase 4Completed

TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis

Duke University·interventional·Posted Jan 9, 2014·Updated Dec 5, 2018

In Brief

A Phase 4 clinical trial evaluating Amicar and TXA for Blood Loss and 2 related conditions. Completed, enrolled 246 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty. Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay. Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar. A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 9, 2014
Enrollment StartJan 1, 2015
Primary CompletionNov 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.5 years ago

Interventions

Amicardrug

Subjects randomized to receive Amicar will receive this during surgical intervention

TXAdrug

Subjects randomized to receive TXA will receive this during surgical intervention