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

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 Overview

• Status: Completed
• Conditions: Blood Loss; Knee Arthritis; Hip Arthritis
• Intervention / Treatment: Drug: TXA; Drug: Amicar

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic Acid (TXA); 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; Subjects randomized to receive TXA will receive this during surgical intervention; Other Names: Tranexamic Acid
Active Comparator: Epsilon-aminocaproic acid (Amicar); 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; Subjects randomized to receive Amicar will receive this during surgical intervention; Other Names: Aminocaproic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 12, 2017
• Study Completion (Actual): November 12, 2017

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid; Aminocaproic Acid
• Other Study ID Numbers: Pro00050108