Deep Venous Thrombosis and Long Term Complications

February 19, 2026 updated by: Ove Andersen

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Biomarkers and long term complications in DVT patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days
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
12 months
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
12 months
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
24 months
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.
90 days
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.
12 months
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.
24 months
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
24 months
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
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days
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.
12 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ove Andersen

Investigators

  • Principal Investigator: Ove Andersen, M.D., Ph.D., Department of Clinical Research
  • Study Chair: Izzet Altintas, M.D., Department of Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21061004 / 85280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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