About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or above
First time lower extremity DVT
Hospitalized at the Emergency Department
Disqualifiers
Patients without a Danish social security number
Terminal patients
Patients who do not understand or speak Danish
Trial design
Single group
Treatments tested in this trial
Blood sample and Ultrasound examination
Diagnostic testThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Change in suPAR - 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
Secondary outcomes
Change in suPAR - 90 days
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 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
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.
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.
Other outcomes
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.
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.
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.
Sponsors and contacts
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Ove Andersen
Lead sponsor
Hvidovre University Hospital
Sponsor institution