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Deep Venous Thrombosis and Long Term Complications

Primary Purpose

DVT of Legs

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Blood sample and Ultrasound examination
Sponsored by
Ove Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for DVT of Legs focused on measuring DVT, aging, inflammation, anti-inflammation, immune system, PTS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Copenhagen University Hospital HvidovreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biomarkers and long term complications in DVT patients

Arm 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.

Outcomes

Primary Outcome Measures

suPAR - baseline
suPAR level in first-time DVT patients at the time of diagnosis (baseline)
Change in suPAR - 90 days
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 90 days
Change in suPAR - 12 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 12 months
Change in suPAR - 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
Association of suPAR and PTS - baseline
Association of suPAR and development of PTS in DVT patients from the time of diagnosis (baseline)
Association of suPAR and PTS - 90 days
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis
Association of suPAR and PTS - 12 month
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 12 months after diagnosis
Association of suPAR and PTS - 24 month
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 24months after diagnosis

Secondary Outcome Measures

Biomarkers in DVT patients - baseline
Biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) at baseline.
Biomarkers in DVT patients - change over time 90 days
Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) from time of diagnosis (baseline) to 90 days after diagnosis.
Biomarkers in DVT patients - change over time 12 months
Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) from time of diagnosis (baseline) to 12 months after diagnosis.
Biomarkers in DVT patients - change over time 24 months
Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) from time of diagnosis (baseline) to 24 months after diagnosis.
PTS in DVT patients - 90 days
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 90 days after diagnosis.
PTS in DVT patients - 12 months
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 12 months after diagnosis.
PTS in DVT patients - 24 months
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 24 months after diagnosis.

Full Information

First Posted
February 13, 2023
Last Updated
March 15, 2023
Sponsor
Ove Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT05789108
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
March 9, 2026 (Anticipated)
Study Completion Date
March 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ove Andersen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DVT of Legs
Keywords
DVT, aging, inflammation, anti-inflammation, immune system, PTS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biomarkers and long term complications in DVT patients
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample and Ultrasound examination
Intervention Description
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.
Primary Outcome Measure Information:
Title
suPAR - baseline
Description
suPAR level in first-time DVT patients at the time of diagnosis (baseline)
Time Frame
Baseline
Title
Change in suPAR - 90 days
Description
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 90 days
Time Frame
90 days
Title
Change in suPAR - 12 months
Description
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 12 months
Time Frame
12 months
Title
Change in suPAR - 24 months
Description
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
Time Frame
24 months
Title
Association of suPAR and PTS - baseline
Description
Association of suPAR and development of PTS in DVT patients from the time of diagnosis (baseline)
Time Frame
Baseline
Title
Association of suPAR and PTS - 90 days
Description
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis
Time Frame
90 days
Title
Association of suPAR and PTS - 12 month
Description
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 12 months after diagnosis
Time Frame
12 months
Title
Association of suPAR and PTS - 24 month
Description
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 24months after diagnosis
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Biomarkers in DVT patients - baseline
Description
Biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) at baseline.
Time Frame
Baseline
Title
Biomarkers in DVT patients - change over time 90 days
Description
Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) from time of diagnosis (baseline) to 90 days after diagnosis.
Time Frame
90 days
Title
Biomarkers in DVT patients - change over time 12 months
Description
Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) from time of diagnosis (baseline) to 12 months after diagnosis.
Time Frame
12 months
Title
Biomarkers in DVT patients - change over time 24 months
Description
Change in biomarkers concerning inflammatory, anti-inflammatory, immunological and aging/ senescent cells (IL-1β, IL-6, IL-10, IL-15, IL-18, Trombin, Fibrin/ Fibrinogen, GDF-8, GDF-15, COX2, PGE2, CD57, Cystatin C, NGAL, FGF-21, FGF-23, MICA, ULBP2, Klotho, p16INK4a, p21Cip1, asparagine endopeptidase, DPP4, KLRG1, DNA-methylering, U-PA, Vitronectin, PAI-1, Tissue Factor, histoner, kromatin and NETs) from time of diagnosis (baseline) to 24 months after diagnosis.
Time Frame
24 months
Title
PTS in DVT patients - 90 days
Description
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 90 days after diagnosis.
Time Frame
90 days
Title
PTS in DVT patients - 12 months
Description
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 12 months after diagnosis.
Time Frame
12 months
Title
PTS in DVT patients - 24 months
Description
Development of PTS in DVT patients from the time of diagnosis (baseline) and up to 24 months after diagnosis.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Izzet Altintas, M.D.
Phone
004531252292
Email
izzet.altintas@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ove Andersen, M.D., Ph.D.
Phone
004529333262
Email
ove.andersen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ove Andersen, M.D., Ph.D.
Organizational Affiliation
Department of Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Izzet Altintas, M.D.
Organizational Affiliation
Department of Clinical Research
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izzet Altintas, M.D.
Phone
+4531252292
Email
izzet.altintas@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ove Andersen, M.D., Ph.D.
Phone
004538623335
Email
ove.andersen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Deep Venous Thrombosis and Long Term Complications

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