The Correlation of Lewis Antigens With VTE

NCT07402005 | Not Yet Recruiting

• 1 other identifier: 52424
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thromboembolic Disease

Keywords

VTE, LEWIS ANTIGEN

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  From enrollment to the day of blood antigen phenotyping- approximately 48 hours

Study Arms (2)

Patients with personal history of VTE

BLODD SAMPLING

CONTROL GROUP- VOLUNTEERS BLOOD DONORS

CONTROL GROUP- HEALTHY BLOOD DONORS

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pateints with personal history of VTE

You may qualify if:

• Adult patients aged 18-78 years with a personal history of deep venous thrombosis and/or Pulmonary Embolism.

Sponsors & Collaborators

• Larissa University Hospital: lead

Related Publications (5)

• 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.

  PMID: 23562273 BACKGROUND

• Hein 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.

  PMID: 1474347 BACKGROUND

• Ellison 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.

  PMID: 10072221 BACKGROUND

• Salomaa 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.

  PMID: 10886491 BACKGROUND

• Bharath 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.

  PMID: 34974187 BACKGROUND

Related Links

• University Hospital of Larissa, Thessaly

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paraskevi Kotsi, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Eleftheria Lefkou, MD, MPA, PhD

CONTACT

0030 6932299014; elefkou@gmail.com

Eleni Georgiadi, MD, PhD

CONTACT

00306977078761; georgiadie@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Transfusion Medicine

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 11, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share