The Correlation of Lewis Antigens With VTE

February 3, 2026 updated by: Eleftheria Lefkou, Larissa University Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

  • Name: Eleftheria Lefkou, MD, MPA, PhD
  • Phone Number: 0030 6932299014
  • Email: elefkou@gmail.com

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pateints with personal history of VTE

Description

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

-

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

Cohorts and Interventions

Group / Cohort
Patients with personal history of VTE
BLODD SAMPLING
CONTROL GROUP- VOLUNTEERS BLOOD DONORS
CONTROL GROUP- HEALTHY BLOOD DONORS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the day of blood phenotyping- approximately 48 hours
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
From enrollment to the day of blood antigen phenotyping- approximately 48 hours

Collaborators and Investigators

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

Sponsor

Larissa University Hospital

Investigators

  • Study Chair: Paraskevi Kotsi, MD, PhD, Blood Transfusion and Haemostasis Unit, Faculty Of Medicine, School Of Health Sciences, University of Thessaly, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

January 19, 2026

Primary Completion (Estimated)

January 18, 2027

Study Completion (Estimated)

January 18, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Study Data/Documents

  1. Study Protocol
    Information identifier: 52424
    Information comments: https://www.uhl.gr/

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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