The Incidence of Venous Thromboembolism in Atopic Dermatitis

October 22, 2024 updated by: Momentum Data

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

754745

Contacts and Locations

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

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.

Description

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.

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Other: Exposure of venous thromboembolism
Composite of pulmonary embolism and deep vein thrombosis
Controls
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Other: Exposure of venous thromboembolism
Composite of pulmonary embolism and deep vein thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years from index date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years from index date
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.
10 years from index date
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.
10 years from index date
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.
10 years from index date
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.
10 years from index date
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.
10 years from index date
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.
10 years from index date
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.
10 years from index date
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 years from index date
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.
10 years from index date
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.
10 years from index date

Collaborators and Investigators

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

Sponsor

Momentum Data

Collaborators

Pfizer

Investigators

  • Study Director: Andrew McGovern, MD, Momentum Data Ltd

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 (Actual)

June 21, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

OPCRD data can be accessed by bone fide researchers for specific research projects, subject to approval by Anonymised Data Ethics & Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.

IPD Sharing Time Frame

The data will be available subject to approvals for two years after the study publication date

IPD Sharing Access Criteria

Data sharing is subject to ADEPT committee approval

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

Clinical Trials on Allergic Rhinitis

Clinical Trials on Exposure of venous thromboembolism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe