DVT of LegsNCT05789108
Deep Venous Thrombosis and Long Term Complications
A study testing Blood sample and Ultrasound examination in people with DVT of Legs, run by Ove Andersen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DVT of Legs
- What is being tested?
- Blood sample and Ultrasound examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Mar 2023to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or above
- First time lower extremity DVT
- Hospitalized at the Emergency Department
Who cannot join
- Patients without a Danish social security number
- Terminal patients
- Patients who do not understand or speak Danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, 2650
Izzet Altintas, M.D., +4531252292, izzet.altintas@regionh.dk
Ove Andersen, M.D., Ph.D., 004538623335, ove.andersen@regionh.dk
About this study
Official title: Deep Venous Thrombosis and Risk of Long Term Complications in Acutely Admitted Patients
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
Read the 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
- Being tested
- Blood sample and Ultrasound examination
- Keywords
- DVT, aging, inflammation, anti-inflammation, immune system, PTS
- Medical subject headings
- Venous Thrombosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and Ultrasound examinationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Biomarkers and long term complications in DVT patients | Other | 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. Receives: Diagnostic Test: Blood sample and Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Change in suPAR - 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
Measured: 24 months
Secondary outcomes (9)
Change in suPAR - 90 days
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 90 days
Measured: 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
Measured: 12 months
Prevalence of 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.
Measured: 90 days
Prevalence of 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.
Measured: 12 months
Prevalence of 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.
Measured: 24 months
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
Measured: 12 months
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
Measured: 24 months
Change in suPAR in patients with prior sars-CoV-2 infection - 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months - stratified by patients prior sars-CoV-2 infection status
Measured: 24 months
Association of suPAR and PTS in patients with prior sars-CoV-2 infection - 90 days
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis - stratified by patients prior sars-CoV-2 infection status
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start14 Mar 2023
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVT of LegsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ove Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, M.D., Ph.D., Principal investigator, Department of Clinical ResearchIzzet Altintas, M.D., Study chair, Department of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789108
- Sponsor's protocol ID
- H-21061004 / 85280
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Venous Thrombosis and Risk of Long Term Complications in Acutely Admitted Patients
- ClinicalTrials.gov ID
- NCT05789108
- Acronym / sponsor ID
- H-21061004 / 85280
- Conditions
- DVT of Legs
- Keywords
- DVT, aging, inflammation, anti-inflammation, immune system, PTS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Ove AndersenUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarkers and long term complications in DVT patients | Other | Diagnostic Test: Blood sample and Ultrasound examinationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or above
- First time lower extremity DVT
- Hospitalized at the Emergency Department
Key exclusion criteria (3 listed)
- Patients without a Danish social security number
- Terminal patients
- Patients who do not understand or speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample and Ultrasound examinationThe 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. | Diagnostic test | Biomarkers and long term complications in DVT patients |
Primary outcome
Association of suPAR and PTS - 90 days
Time frame: 90 days
Association of suPAR and development of PTS in DVT patients from the time of diagnosis and 90 days after diagnosis
Change in suPAR - 24 months
Time frame: 24 months
Change in suPAR level in first-time DVT patients from the time of diagnosis (baseline) to 24 months
9 secondary outcomes
Change in suPAR - 90 days
Time frame: 90 days
Change in suPAR - 12 months
Time frame: 12 months
Prevalence of PTS in DVT patients - 90 days
Time frame: 90 days
Prevalence of PTS in DVT patients - 12 months
Time frame: 12 months
Prevalence of PTS in DVT patients - 24 months
Time frame: 24 months
Association of suPAR and PTS - 12 month
Time frame: 12 months
Association of suPAR and PTS - 24 month
Time frame: 24 months
Change in suPAR in patients with prior sars-CoV-2 infection - 24 months
Time frame: 24 months
Association of suPAR and PTS in patients with prior sars-CoV-2 infection - 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for DVT of Legs
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Recruiting
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
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RecruitingObservational study
Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
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Not yet recruiting
Acute or Subacute Iliofemoral Vein Thrombosis: Aspiration for Flow Restoration Versus Standard Anticoagulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ove Andersen, M.D., Ph.D. principal investigator
Department of Clinical Research
Izzet Altintas, M.D. study chair
Department of Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Ultrasound examination in people with DVT of Legs, run by Ove Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Izzet Altintas, M.D. (004531252292, izzet.altintas@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of suPAR and PTS - 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.