Deep Venous Thrombosis and Long Term Complications

Ove Andersen

Status: Enrolling

Conditions: DVT of Legs

Treatments: Diagnostic Test: Blood sample and Ultrasound examination

Study type: Interventional

Funder types: Other

Identifiers

NCT05789108

H-21061004 / 85280

Details and patient eligibility

About

In this cohort study, the investigators will investigate the concentration of biomarkers, e.g., inflammatory, anti-inflammatory, immunological, senescent, biochemical ratio-calculations and blood cell type among first time lower extremity deep venous thrombosis patients with and without SARS-CoV-2 infection and long term complications with a 2-year follow-up.

Full 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 hypothesis are:

i. 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

ii. There is an elevated level of the biomarkers: suPAR, D-dimer, inflammatory, anti-inflammatory, immunological, and aging markers at the time of diagnosis of DVT in patients with SARS-CoV-2 infection compared to DVT patients without SARS-CoV-2 infection.

iii. There is an increased incidence of late complications such as PTS among DVT patients with SARS-CoV-2 infection compared to DVT patients without SARS-CoV-2 infection

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 (0-24 months) 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Biomarkers and long term complications in DVT patients

Other group

Description:

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.

Treatment:

Diagnostic Test: Blood sample and Ultrasound examination