TXA vs. Amicar in Total Knee and Hip Arthroplasty

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030821
• Other study ID #: Pro00050108
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: November 12, 2017

Study information

• Verified date: November 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: November 12, 2017
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Blood Loss
• Hip Arthritis
• Knee Arthritis

Intervention

Drug:
• Amicar
Subjects randomized to receive Amicar will receive this during surgical intervention
• TXA
Subjects randomized to receive TXA will receive this during surgical intervention

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Transfusions		Participants will be followed for the duration of hospital stay, an expected average of 5 days
Primary	Difference in Preoperative and Lowest Postoperative Hemoglobin		Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Length of Hospitalization Stay		Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Cost of Hospitalization		Participants will be followed for the duration of hospital stay, an expected average of 5 days