Clinical trial NCT05789108: Deep Venous Thrombosis and Long Term Complications
Official title: Deep Venous Thrombosis and Risk of Long Term Complications in Acutely Admitted Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: DVT of Legs
Keywords: DVT
aging
inflammation
anti-inflammation
immune system
PTS
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: suPAR - baseline
timeFrame: Baseline
measure: Change in suPAR - 90 days
timeFrame: 90 days
measure: Change in suPAR - 12 months
timeFrame: 12 months
measure: Change in suPAR - 24 months
timeFrame: 24 months
measure: Association of suPAR and PTS - baseline
timeFrame: Baseline
measure: Association of suPAR and PTS - 90 days
timeFrame: 90 days
measure: Association of suPAR and PTS - 12 month
timeFrame: 12 months
measure: Association of suPAR and PTS - 24 month
timeFrame: 24 months
Secondary outcomes:
measure: Biomarkers in DVT patients - baseline
timeFrame: Baseline
measure: Biomarkers in DVT patients - change over time 90 days
timeFrame: 90 days
measure: Biomarkers in DVT patients - change over time 12 months
timeFrame: 12 months
measure: Biomarkers in DVT patients - change over time 24 months
timeFrame: 24 months
measure: PTS in DVT patients - 90 days
timeFrame: 90 days
measure: PTS in DVT patients - 12 months
timeFrame: 12 months
measure: PTS in DVT patients - 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
state: Copenhagen
Study officials:
affiliation: Department of Clinical Research
name: Ove Andersen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Research
name: Izzet Altintas, M.D.
role: STUDY_CHAIR
References: