Tranexamic Acid and Blood Clots in Knee Surgery

Completed

• Conditions: Venous Thrombosis
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT02867163
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2017-05-16
• Primary Completion: 2017-11-08
• Study Completion: 2017-11-08
• Status Verified: 2019-02
• Results First Submitted: 2019-02-20
• Results First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Results First Posted: 2019-05-20
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee replacement patients receiving TXA	Tranexamic Acid	Patients who receive tranexamic acid during total knee replacement surgery

Primary Outcome Measures

Name	Time	Method
Deep Vein Thrombosis	One day	Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1

Trial Locations

Locations (1)

Sandoval Regional Medical Center; 🇺🇸 Rio Rancho, New Mexico, United States