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Tranexamic Acid and Blood Clots in Knee Surgery

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ClinicalTrials.gov Identifier: NCT02867163
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
David Siegel, University of New Mexico

Brief Summary:
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.

Condition or disease Intervention/treatment
Venous Thrombosis Drug: Tranexamic Acid

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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Does the Intraoperative Administration of Tranexamic Acid (TXA) Increase the Incidence of Deep Venous Thrombosis in Total Knee Arthroplasty?
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Deep Vein Thrombosis [ Time Frame: One day ]
    Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867163


Locations
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United States, New Mexico
Sandoval Regional Medical Center
Rio Rancho, New Mexico, United States, 87144
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: David Siegel, MD University of New Mexico
  Study Documents (Full-Text)

Documents provided by David Siegel, University of New Mexico:

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Responsible Party: David Siegel, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT02867163     History of Changes
Other Study ID Numbers: TXA in TKR
First Posted: August 15, 2016    Key Record Dates
Results First Posted: May 20, 2019
Last Update Posted: May 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants