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TXA vs. Amicar in Total Knee and Hip Arthroplasty

Primary Purpose

Blood Loss, Hip Arthritis, Knee Arthritis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amicar
TXA
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tranexamic Acid (TXA)

Epsilon-aminocaproic acid (Amicar)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
Number of Transfusions
Difference in Preoperative and Lowest Postoperative Hemoglobin

Secondary Outcome Measures

Length of Hospitalization Stay
Cost of Hospitalization

Full Information

First Posted
January 6, 2014
Last Updated
November 9, 2018
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02030821
Brief Title
TXA vs. Amicar in Total Knee and Hip Arthroplasty
Official Title
TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
November 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Hip Arthritis, Knee Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid (TXA)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Epsilon-aminocaproic acid (Amicar)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amicar
Other Intervention Name(s)
Aminocaproic Acid
Intervention Description
Subjects randomized to receive Amicar will receive this during surgical intervention
Intervention Type
Drug
Intervention Name(s)
TXA
Other Intervention Name(s)
Tranexamic Acid
Intervention Description
Subjects randomized to receive TXA will receive this during surgical intervention
Primary Outcome Measure Information:
Title
Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Number of Transfusions
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Difference in Preoperative and Lowest Postoperative Hemoglobin
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Length of Hospitalization Stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Cost of Hospitalization
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States

12. IPD Sharing Statement

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TXA vs. Amicar in Total Knee and Hip Arthroplasty

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