Thromboembolic DiseaseNCT07402005
The Correlation of Lewis Antigens With VTE
An observational study of Thromboembolic Disease, run by Larissa University Hospital.
Trial summary
The goal of this observational study is to learn if certain factors in a person's blood are linked to a history of venous thromboembolic disease (VTED), which includes conditions like deep vein thrombosis. Lewis system antigens are natural markers found on red blood cells. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Thromboembolic Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2026to 18 Jan 2027
- 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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pateints with personal history of VTE
Who may be able to join
- Adult patients aged 18-78 years with a personal history of deep venous thrombosis and/or Pulmonary Embolism.
- Exclusion Criteria:1. Current pregnancy or postpartum period 2. Hepatic insufficiency 3. Alcoholic cirrhosis
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation of Lewis Erythrocyte Antigens With the Risk of Venous Thromboembolic Disease-VTE
The goal of this observational study is to learn if certain factors in a person's blood are linked to a history of venous thromboembolic disease (VTED), which includes conditions like deep vein thrombosis.
Lewis system antigens are natural markers found on red blood cells. Past research suggests that people without these specific markers might have a higher chance of developing heart disease, but the link to blood clots in veins is not well understood.
Read more
This study aims to answer:
- Are certain Lewis antigen types more common in people with a history of VTE?
- Do the Lewis antigen results relate to other known blood clot risk factors? Researchers will identify Lewis a and b antigens in 100 participants who attend the Haemostasis Disorders Clinic at the University Hospital of Larissa. All participants are people with a personal history of deep vein thrombosis, with or without an inherited or acquired tendency for blood clots.
Researchers will also record other known risk factors for VTED for each participant. This study is self-funded.
Read the detailed description
Background Since 1992, research has reported a correlation between Lewis antigens and cardiovascular disease, primarily linked to increased endothelial activation in individuals who are Lewis a(-) b(-). Experimental studies in mice suggest an association between the FUT4 and FUT7 genes and the occurrence of venous thromboembolic disease (VTED), but there is a lack of in vivo studies on this subject in humans . This study aims to fill this knowledge gap by investigating this relationship in a clinical setting.
Study Objectives The primary objective is to investigate the relationship between Lewis system antigens and a personal history of VTED. The study will also assess the association between specific Lewis antigen phenotypes and other known risk factors for VTED.
Study Design This is an independent and self-funded, single-center, observational study (p. 1). Lewis a and b antigens will be identified serologically in a specific patient population, and these results will be correlated with existing clinical data on thrombophilia and other VTE risk factors Study Population and Setting The study will include 100 participants (goal sample size for 90% statistical power) with a personal history of deep vein thrombosis, regardless of whether they have hereditary or acquired thrombophilia . All participants are monitored at the Haemostasis Disorders Clinic of the Blood Transfusion Service at the University Hospital of Larissa, Greece. Written informed consent is obtained from all participants after they are fully informed about the study.
Methods and Outcome Measures Lewis antigens are identified using commercial reagents and gel cards from Grifols.
Primary Outcome Measure: The prevalence of different Lewis erythrocyte antigen phenotypes in patients with a history of VTED. (Time Frame: At the time of a single blood draw) Secondary Outcome Measure: The correlation between Lewis phenotypes and the presence of other known VTE risk factors or a confirmed diagnosis of thrombophilia. (Time Frame: Assessed using existing medical records at the time of a single blood draw) Statistical Analysis Statistical analysis will be performed using the SPSS software package.
- Conditions
- Thromboembolic Disease
- Keywords
- VTE, LEWIS ANTIGEN
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with personal history of VTE | BLODD SAMPLING | |
| CONTROL GROUP- VOLUNTEERS BLOOD DONORS | CONTROL GROUP- HEALTHY BLOOD DONORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to investigate the relationship between Lewis system antigens and venous thromboembolic disease (VTED).
Lewis a and b antigens will be identified in patients with a personal history of deep vein thrombosis, with or without hereditary or acquired thrombophilia, who are being monitored at the Haemostasis Disorders Clinic of the Blood Transfusion Service of the University Hospital of Larissa. All patients, after being informed, will submit written consent for their participation in the study.
Lewis antigens will be identified serologically using reagents and gel cards from Grifols. The results of the thrombophilia test and other known risk factors for VTE will be recorded. Statistical analysis will be performed using the SPSS package.
Measured: From enrollment to the day of blood phenotyping- approximately 48 hours
PRESENCE OF LEWIS A AND B ANTIGEN ON ERYTHROCYTE
NEGATIVE OR POSITIVE FOR LEWIS ANTIGENS
Measured: From enrollment to the day of blood antigen phenotyping- approximately 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start19 Jan 2026 (estimated)
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thromboembolic DiseaseStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleftheria Lefkou, Larissa University Hospital
- Investigators
- Paraskevi Kotsi, MD, PhD, Study chair, Blood Transfusion and Haemostasis Unit, Faculty Of Medicine, School Of Health Sciences, University of Thessaly, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402005
- Sponsor's protocol ID
- 52424
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our study does not plan to share Individual Participant Data (IPD) primarily due to strict limitations in the original informed consent process; participants did not grant permission for their data to be shared externally.
Publications
Wang H, Morales-Levy M, Rose J, Mackey LC, Bodary P, Eitzman D, Homeister JW. alpha(1,3)-Fucosyltransferases FUT4 and FUT7 control murine susceptibility to thrombosis. Am J Pathol. 2013 Jun;182(6):2082-93. doi: 10.1016/j.ajpath.2013.02.010. Epub 2013 Apr 2.
PubMed 23562273Hein HO, Sorensen H, Suadicani P, Gyntelberg F. The Lewis blood group--a new genetic marker of ischaemic heart disease. J Intern Med. 1992 Dec;232(6):481-7. doi: 10.1111/j.1365-2796.1992.tb00620.x.
PubMed 1474347Ellison RC, Zhang Y, Myers RH, Swanson JL, Higgins M, Eckfeldt J. Lewis blood group phenotype as an independent risk factor for coronary heart disease (the NHLBI Family Heart Study). Am J Cardiol. 1999 Feb 1;83(3):345-8. doi: 10.1016/s0002-9149(98)00866-2.
PubMed 10072221Salomaa V, Pankow J, Heiss G, Cakir B, Eckfeldt JH, Ellison RC, Myers RH, Hiller KM, Brantley KR, Morris TL, Weston BW. Genetic background of Lewis negative blood group phenotype and its association with atherosclerotic disease in the NHLBI family heart study. J Intern Med. 2000 Jun;247(6):689-98. doi: 10.1046/j.1365-2796.2000.00682.x.
PubMed 10886491Bharath R, Nair KKM, Gupta D, Vijayan R. Assessment of Lewis negative phenotype as a risk factor for multivessel disease in patients with acute coronary syndrome. Transfus Clin Biol. 2022 May;29(2):129-133. doi: 10.1016/j.tracli.2021.12.008. Epub 2021 Dec 30.
PubMed 34974187
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Lewis Erythrocyte Antigens With the Risk of Venous Thromboembolic Disease-VTE
- ClinicalTrials.gov ID
- NCT07402005
- Acronym / sponsor ID
- 52424
- Conditions
- Thromboembolic Disease
- Keywords
- VTE, LEWIS ANTIGEN
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- 19 Jan 2026 (estimated)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 11 Feb 2026 (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.
The goal of this observational study is to learn if certain factors in a person's blood are linked to a history of venous thromboembolic disease (VTED), which includes conditions like deep vein thrombosis.
Lewis system antigens are natural markers found on red blood cells. Past research suggests that people without these specific markers might have a higher chance of developing heart disease, but the link to blood clots in veins is not well understood.
This study aims to answer:
- Are certain Lewis antigen types more common in people with a history of VTE?
- Do the Lewis antigen results relate to other known blood clot risk factors? Researchers will identify Lewis a and b antigens in 100 participants who attend the Haemostasis Disorders Clinic at the University Hospital of Larissa. All participants are people with a personal history of deep vein thrombosis, with or without an inherited or acquired tendency for blood clots.
Researchers will also record other known risk factors for VTED for each participant. This study is self-funded.
Detailed description
Background Since 1992, research has reported a correlation between Lewis antigens and cardiovascular disease, primarily linked to increased endothelial activation in individuals who are Lewis a(-) b(-). Experimental studies in mice suggest an association between the FUT4 and FUT7 genes and the occurrence of venous thromboembolic disease (VTED), but there is a lack of in vivo studies on this subject in humans . This study aims to fill this knowledge gap by investigating this relationship in a clinical setting.
Study Objectives The primary objective is to investigate the relationship between Lewis system antigens and a personal history of VTED. The study will also assess the association between specific Lewis antigen phenotypes and other known risk factors for VTED.
Study Design This is an independent and self-funded, single-center, observational study (p. 1). Lewis a and b antigens will be identified serologically in a specific patient population, and these results will be correlated with existing clinical data on thrombophilia and other VTE risk factors Study Population and Setting The study will include 100 participants (goal sample size for 90% statistical power) with a personal history of deep vein thrombosis, regardless of whether they have hereditary or acquired thrombophilia . All participants are monitored at the Haemostasis Disorders Clinic of the Blood Transfusion Service at the University Hospital of Larissa, Greece. Written informed consent is obtained from all participants after they are fully informed about the study.
Methods and Outcome Measures Lewis antigens are identified using commercial reagents and gel cards from Grifols.
Primary Outcome Measure: The prevalence of different Lewis erythrocyte antigen phenotypes in patients with a history of VTED. (Time Frame: At the time of a single blood draw) Secondary Outcome Measure: The correlation between Lewis phenotypes and the presence of other known VTE risk factors or a confirmed diagnosis of thrombophilia. (Time Frame: Assessed using existing medical records at the time of a single blood draw) Statistical Analysis Statistical analysis will be performed using the SPSS software package.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with personal history of VTE | – | –BLODD SAMPLING |
| CONTROL GROUP- VOLUNTEERS BLOOD DONORS | – | –CONTROL GROUP- HEALTHY BLOOD DONORS |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pateints with personal history of VTE
Key inclusion criteria (3 listed)
- Adult patients aged 18-78 years with a personal history of deep venous thrombosis and/or Pulmonary Embolism.
- Exclusion Criteria:1. Current pregnancy or postpartum period 2. Hepatic insufficiency 3. Alcoholic cirrhosis
- -
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.
Primary outcome
The aim of this study is to investigate the relationship between Lewis system antigens and venous thromboembolic disease (VTED).
Time frame: From enrollment to the day of blood phenotyping- approximately 48 hours
Lewis a and b antigens will be identified in patients with a personal history of deep vein thrombosis, with or without hereditary or acquired thrombophilia, who are being monitored at the Haemostasis Disorders Clinic of the Blood Transfusion Service of the University Hospital of Larissa. All patients, after being informed, will submit written consent for their participation in the study. Lewis antigens will be identified serologically using reagents and gel cards from Grifols. The results of the thrombophilia test and other known risk factors for VTE will be recorded. Statistical analysis will be performed using the SPSS package.
PRESENCE OF LEWIS A AND B ANTIGEN ON ERYTHROCYTE
Time frame: From enrollment to the day of blood antigen phenotyping- approximately 48 hours
NEGATIVE OR POSITIVE FOR LEWIS ANTIGENS
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 11 Feb 2026.
- Background: PubMed 23562273Wang H, Morales-Levy M, Rose J, Mackey LC, Bodary P, Eitzman D, Homeister JW. alpha(1,3)-Fucosyltransferases FUT4 and FUT7 control murine susceptibility to thrombosis. Am J Pathol. 2013 Jun;182(6):2082-93. doi: 10.1016/j.ajpath.2013.02.010. Epub 2013 Apr 2.
- Background: PubMed 1474347Hein HO, Sorensen H, Suadicani P, Gyntelberg F. The Lewis blood group--a new genetic marker of ischaemic heart disease. J Intern Med. 1992 Dec;232(6):481-7. doi: 10.1111/j.1365-2796.1992.tb00620.x.
- Background: PubMed 10072221Ellison RC, Zhang Y, Myers RH, Swanson JL, Higgins M, Eckfeldt J. Lewis blood group phenotype as an independent risk factor for coronary heart disease (the NHLBI Family Heart Study). Am J Cardiol. 1999 Feb 1;83(3):345-8. doi: 10.1016/s0002-9149(98)00866-2.
- Background: PubMed 10886491Salomaa V, Pankow J, Heiss G, Cakir B, Eckfeldt JH, Ellison RC, Myers RH, Hiller KM, Brantley KR, Morris TL, Weston BW. Genetic background of Lewis negative blood group phenotype and its association with atherosclerotic disease in the NHLBI family heart study. J Intern Med. 2000 Jun;247(6):689-98. doi: 10.1046/j.1365-2796.2000.00682.x.
- Background: PubMed 34974187Bharath R, Nair KKM, Gupta D, Vijayan R. Assessment of Lewis negative phenotype as a risk factor for multivessel disease in patients with acute coronary syndrome. Transfus Clin Biol. 2022 May;29(2):129-133. doi: 10.1016/j.tracli.2021.12.008. Epub 2021 Dec 30.
- University Hospital of Larissa, ThessalyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Our study does not plan to share Individual Participant Data (IPD) primarily due to strict limitations in the original informed consent process; participants did not grant permission for their data to be shared externally.
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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.
Paraskevi Kotsi, MD, PhD study chair
Blood Transfusion and Haemostasis Unit, Faculty Of Medicine, School Of Health Sciences, University of Thessaly, Greece
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolic Disease, run by Larissa University Hospital.
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 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Eleftheria Lefkou, MD, MPA, PhD (0030 6932299014, elefkou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this study is to investigate the relationship between Lewis system antigens and venous thromboembolic disease (VTED). (time frame: From enrollment to the day of blood phenotyping- approximately 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07402005, which also lists 5 linked publications.
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 11 Feb 2026.