HypertriglyceridemiaLCGVNCT07200674
Interest of High-speed Centrifugation for Measuring Anti-Xa Activity on Lipemic Plasma
An observational study of Hypertriglyceridemia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Some hemostasis techniques require spectrophotometric measurements. These are then subject to interference from the sample's lipemia (postprandial, hypertriglyceridemia, etc.), which risks distorting the results; this is estimated to affect 0.5 to 2.5% of samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to 11 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient (≥ 18 years) anticoagulated with an anti-Xa
Who may be able to join
- Adult patient (≥ 18 years)
- Patient anticoagulated with an anti-Xa (UFH, LMWH, fondaparinux, danaparoid, apixaban, rivaroxaban)
- Sample sent to the HUS Hematology Laboratory and analyzed for measurement of the anti-Xa activity of an anticoagulant as part of routine care
Who cannot join
- Patient with a basal lipidemic sample
- Sample of insufficient volume
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Hématologie - Unité d'Hémostase - CHU de Strasbourg - France
Strasbourg, 67091
Agathe HERB, PharmD
Agathe HERB, PharmD
About this study
Some hemostasis techniques require spectrophotometric measurements. These are then subject to interference from the sample's lipemia (postprandial, hypertriglyceridemia, etc.), which risks distorting the results; this is estimated to affect 0.5 to 2.5% of samples.
This is particularly the case for anti-Xa activity, a critical test used to monitor anticoagulant treatments.
To date, the HUS Hematology Laboratory does not have or is aware of any alternative method to overcome this interference, and is unable to perform anti-Xa activity when the sample has excessive lipemia. This study will evaluate, on samples from routine care artificially overloaded with lipids, the effectiveness of a high-speed centrifugation process (10,800g for 10 minutes).
- Conditions
- Hypertriglyceridemia
- Keywords
- Hypertriglyceridemia, High-Speed Centrifugation, Anti-Xa Activity, Lipemic Plasma, Hemostasis, Hematology
- Medical subject headings
- Hypertriglyceridemia
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma
To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma, in order to measure anti-Xa activity, and to ensure that this process does not interfere with this measurement.
Measured: Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start11 Mar 2024
- Primary completion11 Dec 2025 (estimated)
- Study completion11 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200674
- Sponsor's protocol ID
- 9241
- Acronym
- LCGV
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of High-speed Centrifugation for Measuring Anti-Xa Activity on Lipemic Plasma
- ClinicalTrials.gov ID
- NCT07200674
- Acronym / sponsor ID
- LCGV / 9241
- Conditions
- Hypertriglyceridemia
- Keywords
- Hypertriglyceridemia, High-Speed Centrifugation, Anti-Xa Activity, Lipemic Plasma, Hemostasis, Hematology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 11 Dec 2025 (estimated)
- Study completion
- 11 Dec 2025 (estimated)
- First posted
- 1 Oct 2025 (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.
Some hemostasis techniques require spectrophotometric measurements. These are then subject to interference from the sample's lipemia (postprandial, hypertriglyceridemia, etc.), which risks distorting the results; this is estimated to affect 0.5 to 2.5% of samples.
This is particularly the case for anti-Xa activity, a critical test used to monitor anticoagulant treatments.
To date, the HUS Hematology Laboratory does not have or is aware of any alternative method to overcome this interference, and is unable to perform anti-Xa activity when the sample has excessive lipemia. This study will evaluate, on samples from routine care artificially overloaded with lipids, the effectiveness of a high-speed centrifugation process (10,800g for 10 minutes).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥ 18 years) anticoagulated with an anti-Xa
Key inclusion criteria (3 listed)
- Adult patient (≥ 18 years)
- Patient anticoagulated with an anti-Xa (UFH, LMWH, fondaparinux, danaparoid, apixaban, rivaroxaban)
- Sample sent to the HUS Hematology Laboratory and analyzed for measurement of the anti-Xa activity of an anticoagulant as part of routine care
Key exclusion criteria (2 listed)
- Patient with a basal lipidemic sample
- Sample of insufficient volume
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma
Time frame: Up to 10 minutes
To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma, in order to measure anti-Xa activity, and to ensure that this process does not interfere with this measurement.
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 1 Oct 2025.
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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.
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 Hypertriglyceridemia, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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 France. 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?
Contact Agathe HERB, PharmD (33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma (time frame: Up to 10 minutes). 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 1 Oct 2025.