TXA vs. Amicar in Total Knee and Hip Arthroplasty

• ClinicalTrials.gov Identifier: NCT02030821
• Recruitment Status: Completed
• First Posted: January 9, 2014
• Results First Posted: December 5, 2018
• Last Update Posted: December 5, 2018
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Blood Loss; Hip Arthritis; Knee Arthritis	Drug: Amicar; Drug: TXA	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
• Study Start Date: January 2015
• Actual Primary Completion Date: November 12, 2017
• Actual Study Completion Date: November 12, 2017

Arms and Interventions

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 Name: 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 Name: Aminocaproic Acid

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. Number of Transfusions [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
3. 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 Measures :

1. Length of Hospitalization Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
2. Cost of Hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27708

Sponsors and Collaborators

Duke University

  Study Documents (Full-Text)

Documents provided by Duke University:

Study Protocol and Statistical Analysis Plan  [PDF] January 15, 2015

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02030821
• Other Study ID Numbers: Pro00050108
• First Posted: January 9, 2014
• Results First Posted: December 5, 2018
• Last Update Posted: December 5, 2018
• Last Verified: November 2018

Additional relevant MeSH terms:

Arthritis; Joint Diseases; Musculoskeletal Diseases; Tranexamic Acid; Aminocaproic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants