TXA vs. Amicar in Total Knee and Hip Arthroplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Loss, Hip Arthritis, Knee Arthritis

Intervention / Treatment
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* Drug: Amicar
* Drug: TXA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic Acid (TXA)<br>TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. 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. | Drug: TXA<br>* Subjects randomized to receive TXA will receive this during surgical intervention<br>* Other names: Tranexamic Acid;|
| Active Comparator: Epsilon-aminocaproic acid (Amicar)<br>Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. 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. | Drug: Amicar<br>* Subjects randomized to receive Amicar will receive this during surgical intervention<br>* Other names: Aminocaproic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Number of Transfusions |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Difference in Preoperative and Lowest Postoperative Hemoglobin |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospitalization Stay |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Cost of Hospitalization |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days |