TXA vs. Amicar in Total Knee and Hip Arthroplasty

• Status: Completed
• Trial end date: 2017-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Aminocaproic Acid; Tranexamic Acid

Criteria

Inclusion Criteria:

• Patients electing to undergo primary total hip or knee arthroplasty

Exclusion Criteria:

• History of stents

• Myocardial infarction,

• Cerebrovascular accident or stroke

• Deep venous thrombus

• Pulmonary embolus

• Late onset color blindness

• Hypercoagulable state