Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789108
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-02-13
Brief Title:
Deep Venous Thrombosis and Long Term Complications
Sponsor:
Ove Andersen
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Deep Venous Thrombosis and Risk of Long Term Complications in Acutely Admitted Patients
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this cohort study the investigators will investigate the concentration of biomarkers eg 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None