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NCT Number: NCT05789108

Deep Venous Thrombosis and Long Term Complications

In this cohort study, the investigators will investigate the concentration of biomarkers, e.g., inflammatory, anti-inflammatory, immunological, senescent, biochemical ratio-calculations, blood cell type, and and long term complications with a 2-year follow-up in patients with first time lower extremity deep venous thrombosis

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Key information

Conditions

DVT of Legs Cardiovascular Diseases Embolism and Thrombosis Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Venous thromboembolism (VTE), which is a common concept for deep venous thrombosis (DVT) and pulmonary embolus (PE), is the third most common cardiovascular disease after myocardial infarction and stroke. The incidence of deep venous thrombosis (DVT) increases exponentially with age and is highest in high-income countries compared to low-income countries. The pathophysiology of DVT is of multicomplex aetiology and there are multifactorial causes leading to the development of DVT. In the long term, patients with DVT can experience reduced thrombus resolution, recurrent thrombosis, and post thrombotic syndrome (PTS), where inflammation has a major impact.

The investigators hypotheses are:

There is an increased level of biomarkers at time of diagnosis among DVT patients who develop PTS compared to DVT patients who do not develop PTS

Purpose:

In this clinical prospective cohort study the investigators will investigate and characterize acutely admitted patients with deep venous thrombosis via inflammatory, anti-inflammatory, immunological and ageing biomarkers to gain a better understanding of options about prevention and treatment of long-term complications

Data collection:

Eligible patients will be included in the Emergency Department by the physician responsible for the treatment.

Variables:

The following variables will be collected at inclusion and 4 follow-up visits: information on demographics, biomarkers (blood samples and ultrasound scan), clinical data from the patient case report, self-reported information on risk factors, socioeconomic variables, quality of life, and pain. Moreover, register data on socioeconomic status, morbidity, physical health by e.g. Charlson score, mortality, hospital visits, and prescriptions will be retrieved after 2 years of follow-up.

Sample size:

To detect a difference in suPAR (0-24 months) and the association between suPAR and the risk of developing PTS (90 days) a total of 150 participants are needed in the study.

The collected data will be kept in accordance with the Data Protection Agency guidelines. The studies are carried out in accordance with the principles of the Helsinki Declaration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or above
  • First time lower extremity DVT
  • Hospitalized at the Emergency Department

Exclusion criteria

  • Patients without a Danish social security number
  • Terminal patients
  • Patients who do not understand or speak Danish

Treatment and study plan

Blood sample and Ultrasound examination

Diagnostic Test

The ultrasound examination is a non-invasive procedure with no risks, adverse reactions, or discomforts associated with the examination. The study blood samples are mostly obtained at the same time as clinical blood sample collection in order to avoid unnecessary complications.

The inclusion and ultrasound examiniation is performed by the patient responsible physician at the Emergency Department. Blood samples during the study period are performed by trained study staff.

Primary outcomes

  1. Association of suPAR and PTS - 90 days

    Time frame: 90 days

    Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis

  2. Change in suPAR - 24 months

    Time frame: 24 months

    Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months

Secondary outcomes

  1. Change in suPAR - 90 days

    Time frame: 90 days

    Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 90 days

  2. Change in suPAR - 12 months

    Time frame: 12 months

    Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 12 months

  3. Prevalence of PTS in DVT patients - 90 days

    Time frame: 90 days

    Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 90 days after diagnosis.

  4. Prevalence of PTS in DVT patients - 12 months

    Time frame: 12 months

    Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 12 months after diagnosis.

  5. Prevalence of PTS in DVT patients - 24 months

    Time frame: 24 months

    Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 24 months after diagnosis.

  6. Association of suPAR and PTS - 12 month

    Time frame: 12 months

    Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 12 months after diagnosis

  7. Association of suPAR and PTS - 24 month

    Time frame: 24 months

    Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 24months after diagnosis

  8. Change in suPAR in patients with prior sars-CoV-2 infection - 24 months

    Time frame: 24 months

    Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months - stratified by patients prior sars-CoV-2 infection status

  9. Association of suPAR and PTS in patients with prior sars-CoV-2 infection - 90 days

    Time frame: 90 days

    Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis - stratified by patients prior sars-CoV-2 infection status

Other outcomes

  1. Biomarkers in DVT patients - change over time 90 days

    Time frame: 90 days

    Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (in plasma (8 ml): suPAR, IL-1β, IL-6, IL-10, IL-15, IL-18, TNF, trombin, fibrin/fibrinogen, GDF-8, GDF-15, PGE2, cystatin C, NGAL, FGF-21, FGF-23, klotho, DPP4, vitronectin, tissue factor, NET´s, homocystein. in blood cells (24 ml): COX2, CD57, MICA, ULBP2, p16INK4a, p21Cip1 , KLRG1, DNA-methylering, JAK2) from time of diagnosis (baseline) to 90 days after diagnosis.

  2. Biomarkers in DVT patients - change over time 12 months

    Time frame: 12 months

    Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (in plasma (8 ml): suPAR, IL-1β, IL-6, IL-10, IL-15, IL-18, TNF, trombin, fibrin/fibrinogen, GDF-8, GDF-15, PGE2, cystatin C, NGAL, FGF-21, FGF-23, klotho, DPP4, vitronectin, tissue factor, NET´s, homocystein. In blood cells (24 ml): COX2, CD57, MICA, ULBP2, p16INK4a, p21Cip1 , KLRG1, DNA-methylering, JAK2) from time of diagnosis (baseline) to 12 months after diagnosis.

  3. Biomarkers in DVT patients - change over time 24 months

    Time frame: 24 months

    Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (in plasma (8 ml): suPAR, IL-1β, IL-6, IL-10, IL-15, IL-18, TNF, trombin, fibrin/fibrinogen, GDF-8, GDF-15, PGE2, cystatin C, NGAL, FGF-21, FGF-23, klotho, DPP4, vitronectin, tissue factor, NET´s, homocystein. in blood cells (24 ml): COX2, CD57, MICA, ULBP2, p16INK4a, p21Cip1 , KLRG1, DNA-methylering, JAK2) from time of diagnosis (baseline) to 24 months after diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Izzet Altintas, M.D.

CONTACT

[email protected]

004531252292

Ove Andersen, M.D., Ph.D.

CONTACT

[email protected]

004529333262

Sponsors and collaborators

Lead sponsor

Ove Andersen

Other

Registry information

Official study title

Deep Venous Thrombosis and Risk of Long Term Complications in Acutely Admitted Patients

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 29, 2023
Registry last updated
Feb 23, 2026

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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