Tranexamic Acid and Blood Clots in Knee Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-16

Study Completion Date

2017-11-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Venous Thrombosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee replacement patients receiving TXA

Patients who receive tranexamic acid during total knee replacement surgery

Tranexamic Acid

Intervention Type DRUG

Intravenous or local administration of TXA, in any dosage

Interventions

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Tranexamic Acid

Intravenous or local administration of TXA, in any dosage

Intervention Type DRUG

Other Intervention Names

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Lysteda Cyklokapron

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No