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CompletedNCT02648295Updated Oct 26, 2017

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

An observational study in Status Post Total Hip and Knee Arthroplasty, sponsored by West Virginia University. Completed. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by West Virginia University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
40 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Status Post Total Hip and Knee Arthroplasty
03

In context

Lead sponsor

West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adults undergoing primary total hip and knee arthroplasty

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • ProcedureEffects of IV TXA on TEG in patients undergoing THA or TKA

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 months

Secondary outcomes

  1. Blood loss and transfusions

    Estimated and Calculated blood loss and transfusion requirements

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02648295
Lead sponsor
West Virginia University
Responsible party
Matthew Dietz, MD (Assistant Professor, West Virginia University) — Principal investigator
First posted
Jan 7, 2016
Start date
Dec 2015
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Oct 26, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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