An interventional study of Blood sample and Ultrasound examination in DVT of Legs, sponsored by Ove Andersen. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Ove Andersen · Not applicable, Interventional, and Prevention
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
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.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 178 is above the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Ove Andersen is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients with DVT will be enrolled in the study during their hospitalization at the ED. The enrolled patients will have 4 follow-up visits, 1) during the first 14 days after diagnosis, 2) after 3 months, 3) after 12 months and 4) 24 months after the time of diagnosis.
Diagnostic Test: Blood sample and Ultrasound examination
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.
Association of suPAR and PTS - 90 days
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis
Time frame: 90 days
Change in suPAR - 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
Time frame: 24 months
Change in suPAR - 90 days
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 90 days
Time frame: 90 days
Change in suPAR - 12 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 12 months
Time frame: 12 months
Prevalence of PTS in DVT patients - 90 days
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 90 days after diagnosis.
Time frame: 90 days
Prevalence of PTS in DVT patients - 12 months
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 12 months after diagnosis.
Time frame: 12 months
Prevalence of PTS in DVT patients - 24 months
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 24 months after diagnosis.
Time frame: 24 months
Association of suPAR and PTS - 12 month
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 12 months after diagnosis
Time frame: 12 months
Association of suPAR and PTS - 24 month
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 24months after diagnosis
Time frame: 24 months
Change in suPAR in patients with prior sars-CoV-2 infection - 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
Time frame: 24 months
Association of suPAR and PTS in patients with prior sars-CoV-2 infection - 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
Time frame: 90 days
Biomarkers in DVT patients - change over time 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.
Time frame: 90 days
Biomarkers in DVT patients - change over time 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.
Time frame: 12 months
Biomarkers in DVT patients - change over time 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.
Time frame: 24 months
Plan to share: No
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Started Mar 2023 (actual). Primary completion is estimated for Sep 2029, 77 months after the start.
Of 99 non-industry interventional studies with no phase under Venous Thrombosis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 77 months is above that.
Counting every sponsor, half of 117 studies reached it within 34 months; a quarter within 13 and three quarters within 56.
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