Clinical Trials Directory

Trials / Completed

CompletedNCT02030821

TXA vs. Amicar in Total Knee and Hip Arthroplasty

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
246 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAmicarSubjects randomized to receive Amicar will receive this during surgical intervention
DRUGTXASubjects randomized to receive TXA will receive this during surgical intervention

Timeline

Start date
2015-01-01
Primary completion
2017-11-12
Completion
2017-11-12
First posted
2014-01-09
Last updated
2018-12-05
Results posted
2018-12-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02030821. Inclusion in this directory is not an endorsement.