NCT05789108

Deep Venous Thrombosis and Long Term Complications

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Ove Andersen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• DVT of Legs

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-14
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2023-03-29
• Last updated: 2026-02-23

Locations

1 site across 1 country: Denmark