The Correlation of Lewis Antigens With VTE

Official title

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

Overview

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.

Primary outcome measures

• 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]
• PRESENCE OF LEWIS A AND B ANTIGEN ON ERYTHROCYTE [Time frame: From enrollment to the day of blood antigen phenotyping- approximately 48 hours]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 23562273
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07402005 · 52424

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗