Pulmonary EmbolismNCT03275610
Genetic Markers of Patients With History of Pulmonary Embolism Post Total Joint Arthroplasty
An observational study of Pulmonary Embolism, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Blood sample
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 23 Apr 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Established patients with a history of Pulmonary Embolism Post Total Hip Arthroplasty or Post Knee Arthroplasty
Who may be able to join
- patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee Arthroplasty, between the ages of 18 and 70 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Blood sample
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleGenetic
5 mL of blood withdrawn from patients with history of pulmonary embolism post total hip arthroplasty or total joint arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Genetic Mutations
identify the frequency of genetic mutations in patients who have developed a PE after a total joint or total hip arthroplasty
Measured: 6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start24 Apr 2017
- Primary completion23 Apr 2030 (estimated)
- Study completion23 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay R. Lieberman, MD, University of Southern California
- Investigators
- Jay R Lieberman, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275610
- Sponsor's protocol ID
- ORTHO-01
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2017
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification Using Genetic Markers of Patients With a History of Pulmonary Embolism Post Total Hip or Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03275610
- Acronym / sponsor ID
- ORTHO-01
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 23 Apr 2030 (estimated)
- Study completion
- 23 Apr 2035 (estimated)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Established patients with a history of Pulmonary Embolism Post Total Hip Arthroplasty or Post Knee Arthroplasty
Key inclusion criteria (1 listed)
- patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee Arthroplasty, between the ages of 18 and 70 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample5 mL of blood withdrawn from patients with history of pulmonary embolism post total hip arthroplasty or total joint arthroplasty | Genetic | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay R Lieberman, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Genetic Mutations (time frame: 6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.