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The Correlation of Lewis Antigens With VTE

Correlation of Lewis Erythrocyte Antigens With the Risk of Venous Thromboembolic Disease-VTE

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07402005
Enrollment
200
Registered
2026-02-11
Start date
2026-01-19
Completion date
2027-01-18
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolic Disease

Keywords

VTE, LEWIS ANTIGEN

Brief 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. 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.

Interventions

None listed

Sponsors

Larissa University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 \-

Design outcomes

Primary

MeasureTime frameDescription
The aim of this study is to investigate the relationship between Lewis system antigens and venous thromboembolic disease (VTED).From enrollment to the day of blood phenotyping- approximately 48 hoursLewis 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 ERYTHROCYTEFrom enrollment to the day of blood antigen phenotyping- approximately 48 hoursNEGATIVE OR POSITIVE FOR LEWIS ANTIGENS

Contacts

CONTACTEleftheria Lefkou, MD, MPA, PhD
elefkou@gmail.com0030 6932299014
CONTACTEleni Georgiadi, MD, PhD
georgiadie@gmail.com00306977078761
STUDY_CHAIRParaskevi Kotsi, MD, PhD

Blood Transfusion and Haemostasis Unit, Faculty Of Medicine, School Of Health Sciences, University of Thessaly, Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026