Tranexamic Acid and Blood Clots in Knee Surgery

February 20, 2019 updated by: David Siegel, University of New Mexico

Does the Intraoperative Administration of Tranexamic Acid (TXA) Increase the Incidence of Deep Venous Thrombosis in Total Knee Arthroplasty?

This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is anticipated to consist of 30 participants over 18 years of age scheduled for total knee arthroplasty at Sandoval Regional Medical Center with administered intraoperative tranexamic acid, who do not meet the exclusion criteria. The patients will be examined on postoperative day 1. Lower-extremity ultrasound will be used to screen for deep vein thrombosis (DVT). Incidence data for DVT will then be compared with the historical incidence rate at our institution for total knee arthroplasty without the use of tranexamic acid, which is approximately 12%. Patients found on screening to have deep vein thrombosis will be referred for appropriate care.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Rio Rancho, New Mexico, United States, 87144
        • Sandoval Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having total knee replacement at Sandoval Regional Medical Center in Rio Rancho, New Mexico, and who receive an intraoperative dose of tranexamic acid to control surgical bleeding

Description

Inclusion Criteria:

  • Adult patients scheduled for total knee arthroplasty at Sandoval Regional Medical Center with an intraoperative dose of tranexamic acid

Exclusion Criteria:

  • Previous deep vein thrombosis or pulmonary embolism episode
  • Known coronary artery disease or peripheral vascular disease
  • Previously diagnosed hypercoagulable states (e.g. Leiden factor V, antiphospholipid antibody, protein C or S deficiency)
  • Pregnancy
  • Creatinine clearance less than 30 ml/min
  • Non-fluency in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Knee replacement patients receiving TXA
Patients who receive tranexamic acid during total knee replacement surgery
Drug: Tranexamic Acid
Intravenous or local administration of TXA, in any dosage
Other Names:
  • Lysteda
  • Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep Vein Thrombosis
Time Frame: One day
Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: David Siegel, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2017

Primary Completion (Actual)

November 8, 2017

Study Completion (Actual)

November 8, 2017

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA in TKR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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