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

Sponsor
Momentum Data
Study ID
NCT03835780
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • No intervention — OTHER
    A observation of outcomes in usual practice

Study Details

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.

Key Dates

Start date
Feb 1, 2019
Status verified
May 2025
Primary completion
Aug 1, 2019
Completion
Dec 1, 2019

Study Design

Enrollment
266,890 participants (actual)

Arms

  • Arm: People with inflammatory bowel disease
    All individuals with an existing or incident diagnosis of IBD during the study period
  • Arm: People with rheumatoid arthritis
    All individuals with an existing or incident diagnosis of RA during the study period
  • Arm: People with psoriatic arthritis
    All individuals with an existing or incident diagnosis of IBD during the study period
  • Arm: Controls
    Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period

Primary Outcome Measure

Risk of Venous Thromboembolism (VTE) [ Time Frame: A 20 year analysis period (1999-2018 inclusive) ]

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