NCT05789108

Brief 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 thrombosis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Mar 2023Sep 2029

First Submitted

Initial submission to the registry

February 13, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

6.5 years

First QC Date

February 13, 2023

Last Update Submit

February 19, 2026

Conditions

DVT of Legs

Keywords

DVTaginginflammationanti-inflammationimmune systemPTS

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    24 months

Secondary Outcomes (9)

  • Change in suPAR - 90 days

    90 days

  • Change in suPAR - 12 months

    12 months

  • Prevalence of PTS in DVT patients - 90 days

    90 days

  • Prevalence of PTS in DVT patients - 12 months

    12 months

  • Prevalence of PTS in DVT patients - 24 months

    24 months

  • +4 more secondary outcomes

Other Outcomes (3)

  • Biomarkers in DVT patients - change over time 90 days

    90 days

  • Biomarkers in DVT patients - change over time 12 months

    12 months

  • Biomarkers in DVT patients - change over time 24 months

    24 months

Study Arms (1)

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.

Diagnostic Test: Blood sample and Ultrasound examination

Interventions

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.

Biomarkers and long term complications in DVT patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or above
  • First time lower extremity DVT
  • Hospitalized at the Emergency Department

You may not qualify if:

  • Patients without a Danish social security number
  • Terminal patients
  • Patients who do not understand or speak Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Venous ThrombosisInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ove Andersen, M.D., Ph.D.

    Department of Clinical Research

    PRINCIPAL INVESTIGATOR

  • Izzet Altintas, M.D.

    Department of Clinical Research

    STUDY CHAIR

Central Study Contacts

Izzet Altintas, M.D.

CONTACT

004531252292izzet.altintas@regionh.dk

Ove Andersen, M.D., Ph.D.

CONTACT

004529333262ove.andersen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director and Head of the Department of Clinical Research

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 29, 2023

Study Start

March 14, 2023

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)