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NCT Number: NCT03835780

The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study

Blood clots occurring in the legs and in the lungs are relatively common; they occur in around 3 in a 1000 people per year. They can cause disability and are also potentially life threatening. When a clot occurs in the legs it is called a deep vein thrombosis or DVT. When they occur in the lungs they are called a pulmonary embolism or PE. The risk for DVT and PE is higher in people with conditions which cause inflammation. The most common of these are inflammatory bowel disease (ulcerative colitis and Crohn's disease), rheumatoid arthritis, and psoriatic arthritis (a condition comprised of psoriasis and joint inflammation).

What is not known is how much higher the risk of DVT and PE is in these groups compared with people without inflammatory disease, and what causes the excess risk in these people. This study aims to assess the measure the exact increase in risk for DVT and PE in people with these inflammatory conditions and to identify which risk factors are most strongly associated with the increased risk. These data should help with an understand the causes of blood clot risk in these inflammatory conditions and in identify targets for reducing risk.

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Key information

Conditions

Venous Thromboses Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Cardiovascular Diseases Colitis Colitis, Ulcerative Colonic Diseases Connective Tissue Diseases Crohn Disease Deep Vein Thrombosis Digestive System Diseases Embolism Embolism and Thrombosis Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Lung Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Pulmonary Embolism Respiratory Tract Diseases Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Thromboembolism Thrombosis Ulcerative Colitis Vascular Diseases Venous Thromboembolism 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

Background

Venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep vein thrombosis (DVT), are common and associated with significant morbidity and mortality. VTE risk is higher in chronic inflammatory conditions including inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) compared to the general population. Evidence for differential VTE risk in other inflammatory diseases, notably psoriatic arthritis (PsA) and vasculitis, is more limited. Risk factors for VTE have been described in the general population, but there has been little interrogation of VTE risk factors for individuals with chronic inflammatory conditions and their association with subsequent VTE.

Objective

This study aims to describe the prevalence of VTE risk and risk factors in individuals with systemic inflammatory disorders in a contemporary real-world population, by disease type (IBD, RA, and PsA) and relative to a control population without systemic inflammatory disease. In the same cohorts a further comparison will be performed of the influence of VTE risk factors on risk of VTE events in individuals with systemic inflammatory disorders.

Method

A retrospective cohort study will be performed to compare VTE risk and VTE risk factors in adults with IBD, RA, and PsA and matched controls between January 1, 1998 and January 1, 2018, within the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. In the cohorts with and without inflammatory conditions estimate will be determined for the risk of VTE overall, and for PE and DVT separately, using unadjusted Cox proportional hazards models, stratified by matched set (exposed cohort versus unexposed cohort), to provide overall hazard ratios for the association with each outcome. Models will be subsequently adjusted for sociodemographic and clinical and VTE risk factors in multivariable analysis to explore potentially important associations with VTE. The same analyses for each autoimmune condition will be repeated separately. Prespecified sensitivity analyses will be performed to explore the robustness of any potential associations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients (aged ≥18) contributing to RCGP RCS primary care database between January 1, 1998 and January 1, 2018, will be eligible for inclusion

Exclusion criteria

  • People with IBD which cannot be classified or is not ulcerative colitis or Crohn's disease will be excluded.

Treatment and study plan

No intervention

Other

A observation of outcomes in usual practice

Primary outcomes

  1. Risk of Venous Thromboembolism (VTE)

    Time frame: A 20 year analysis period (1999-2018 inclusive)

    Number of participants with systemic inflammatory disorders developing VTE (a composite of pulmonary embolism (PE) and deep vein thrombosis (DVT)) compared to population controls.

Secondary outcomes

  1. Risk of Pulmonary Embolism (PE)

    Time frame: A 20 year analysis period (1999-2018 inclusive)

    Number of participants with systemic inflammatory disorders developing PE compared to population controls.

  2. Risk of Deep Vein Thrombosis (DVT)

    Time frame: A 20 year analysis period (1999-2018 inclusive)

    Number of participants with systemic inflammatory disorders developing DVT compared to population controls.

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Pfizer
  • University of Surrey

Registry information

Official study title

The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a UK Matched Cohort Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
Jun 11, 2025

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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