TXA vs. Amicar in Total Knee and Hip Arthroplasty
Completed · Phase 4
Conditions studied: Blood Loss, Hip Arthritis, Knee Arthritis
In brief
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.
Key facts
- Study ID
- NCT02030821
- Run by
- Duke University
- People needed
- 246
- Starts
- 2015-01-01
- Expected to finish
- 2017-11-12
- Last updated by the study team
- 2018-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients electing to undergo primary total hip or knee arthroplasty
You may not qualify if…
- History of stents
- Myocardial infarction,
- Cerebrovascular accident or stroke
- Deep venous thrombus
- Pulmonary embolus
- Late onset color blindness
- Hypercoagulable state
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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