Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty

Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.

Study Overview

• Status: Completed
• Conditions: Status Post Total Hip and Knee Arthroplasty
• Intervention / Treatment: Procedure: Effects of IV TXA on TEG in patients undergoing THA or TKA

• Study Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults undergoing primary total hip and knee arthroplasty

Description

Inclusion Criteria:

• Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement
• 40-90 years old

Exclusion Criteria:

• Known coagulopathy
• History of venothrombotic event
• Unstable angina
• Recent Myocardial infarction (MI)
• History of bleeding events
• History of chronic anemia
• Preoperative anemia
• Current use of blood thinners including aspirin

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All time measurements which indicate various aspects of clotting cascade	Data derived from the TEG which includes R, MA, LY30 (R = clotting factors, MA clot strength and platelet function and LY30 is fibrinolysis).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss and transfusions	Estimated and Calculated blood loss and transfusion requirements	3 months

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1509851949