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Completed

NCT Number: NCT02867163

Tranexamic Acid and Blood Clots in Knee Surgery

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandoval Regional Medical Center

Rio Rancho, New Mexico, 87144, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tranexamic Acid

Drug

Intravenous or local administration of TXA, in any dosage

Other names: Lysteda, Cyklokapron

Primary outcomes

  1. Deep Vein Thrombosis

    Time frame: One day

    Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2016
Registry last updated
May 20, 2019

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.

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