Completed

NCT Number: NCT02648295

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.

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Key information

Conditions

Status Post Total Hip and Knee Arthroplasty

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effects of IV TXA on TEG in patients undergoing THA or TKA

Procedure

Subjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG.

Primary outcomes

All time measurements which indicate various aspects of clotting cascade

Time frame: 3 months

Data derived from the TEG which includes R, MA, LY30 (R = clotting factors, MA clot strength and platelet function and LY30 is fibrinolysis).

Secondary outcomes

Blood loss and transfusions

Time frame: 3 months

Estimated and Calculated blood loss and transfusion requirements

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 7, 2016
Registry last updated: Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.