Deep Venous Thrombosis and Long Term Complications

ConditionDVT of Legs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOve Andersen

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

178 Participants
are divided into 1 treatment group
Group A: Biomarkers and long term complications in DVT patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ove Andersen

Lead sponsor

Hvidovre University Hospital

Sponsor institution