Genetic Markers of Patients With History of Pulmonary Embolism Post Total Joint Arthroplasty

November 17, 2023 updated by: Jay R. Lieberman, MD, University of Southern California

Risk Stratification Using Genetic Markers of Patients With a History of Pulmonary Embolism Post Total Hip or Total Knee Arthroplasty

This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our translational goal is to ultimately identify certain genetic markers that will allow us to stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The clinical implications for this study would allow for better patient care by lowering the risk of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses (DVTs). We look to sample patients who have a history of PE after undergoing total knee or total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes, allowing for the detection of each allele in a single tube. Using this assay, there is no post-PCR processing because the probes are included in the PCR reaction (Hui). Using this approach, we will measure the frequency of genetic mutations in patients who have developed a PE after a total joint arthroplasty. This data would then be used to perform a prospective study to determine a subset of genetic markers that can definitively be used to risk stratify patients.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Established patients with a history of Pulmonary Embolism Post Total Hip Arthroplasty or Post Knee Arthroplasty

Description

Inclusion Criteria:

  • patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee Arthroplasty, between the ages of 18 and 70 years

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Genetic Mutations
Time Frame: 6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty
identify the frequency of genetic mutations in patients who have developed a PE after a total joint or total hip arthroplasty
6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Jay R Lieberman, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Estimated)

April 23, 2026

Study Completion (Estimated)

April 23, 2026

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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