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Completed

NCT Number: NCT04969653

The Incidence of Venous Thromboembolism in Atopic Dermatitis

This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

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Key information

Conditions

Venous Thromboembolism Allergic Rhinitis Allergy to Animal Dander Allergy to House Dust Mite Atopic Dermatitis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cows Milk Allergy Deep Vein Thrombosis Dermatitis Dermatitis, Atopic Dust Mite Allergy Embolism Embolism and Thrombosis Food Allergy Food Hypersensitivity Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Milk Hypersensitivity Nose Diseases Otorhinolaryngologic Diseases Pulmonary Embolism Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

About this study

The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All eligible adult people (aged ≥ 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.

Exclusion criteria

  • People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.

Treatment and study plan

Exposure of venous thromboembolism

Other

Composite of pulmonary embolism and deep vein thrombosis

Primary outcomes

  1. Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.

    Time frame: 10 years from index date

    To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.

Secondary outcomes

  1. Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.

  2. Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.

  3. Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.

  4. Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.

  5. Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.

  6. Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.

  7. Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.

  8. Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by those with a BMI <30 at the baseline with active AD compared to a matched control population.

    Patients with active AD and missing BMI are excluded along with their related matched cases.

    Patients with active AD and no matched controls with BMI recorded are also excluded.

  9. Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population.

    Patients with active AD and missing BMI are excluded along with their related matched cases.

    Patients with active AD and no matched controls with BMI recorded are also excluded.

  10. Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.

  11. Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    Time frame: 10 years from index date

    To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Pfizer

Registry information

Official study title

The Incidence of Venous Thromboembolism in Atopic Dermatitis: A Matched Cohort Analysis in UK Primary Care

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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