Tranexamic Acid and Blood Clots in Knee Surgery

Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867163
• Other study ID #: TXA in TKR
• Status: Completed
• Start date: May 16, 2017
• Est. completion date: November 8, 2017

Study information

• Verified date: February 2019
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 8, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Tranexamic Acid
Intravenous or local administration of TXA, in any dosage

Locations

Country	Name	City	State
United States	Sandoval Regional Medical Center	Rio Rancho	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deep Vein Thrombosis	Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1	One day