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Biomarkers in Post Thrombotic Syndrome

New Biomarkers in Post Thrombotic Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02376764
Acronym
BIPOSTO
Enrollment
235
Registered
2015-03-03
Start date
2012-02-29
Completion date
2015-02-28
Last updated
2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracellular Matrix Alteration, Postthrombotic Syndrome With Ulcer of Left Lower Extremity

Brief summary

This study aims to deepen the investigators knowledge of Post Thrombotic Syndrome and MMPs (and other related molecules such as TIMPS, NGAL and cytokines) to find a predictive molecular system to better classify the risk of patients to develop a PTS after a DVT episode, in order to monitorate more strictly the patients at high risk for developing this complication.

Detailed description

Post-thrombotic syndrome (PTS) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (DVT) of lower limbs. PTS symptoms include chronic leg pain, swelling, redness, and skin ulcers. PTS lowers patients' quality of life after DVT, specifically with regards to physical and psychological symptoms and limitations in daily activities. Secondly, the treatment of PTS adds significantly to the cost of treating DVT. PTS also causes lost work productivity: patients with severe PTS and venous ulcers lose up to 2 work days per year Nowadays, there are no effective measures to reduces significatively PTS onset following a DVT episode. Biomarkers can be of use in further exploring the etiology as well as in developing risk stratification tools for PTS. The relationship between PTS and specific biomarkers may help guide prevention and therapy based on a patient's individual risk profile. Recent studies showed that MMPs play a significant role in vascular remodeling and endothelial dysfunction and they may explain a role in aneurysm formation as well as in all the clinical manifestations of venous disease (both for acute and chronic related events) but the cellular and molecular mechanisms involved in thrombus resolution and vein wall fibrosis remain undefined. The presence of MMPs and TIMPs in acute venous occlusion model suggests that there is an important early interplay between protease and inhibitor during events that precede the development of venous disease. This study aims to deepen the investigators knowledge of PTS and MMPs (and other related molecules such as NGAL and cytokines) to find a predictive molecular system to better classify the risk of patients to develop a PTS after a DVT episode, in order to monitorate more strictly the patients at high risk for developing this complication. Patients will be recruited at their first episode of DVT and will be followed up according to standard protocols for DVT at 1,4,8,12,24, 36 months. At each visit blood sample will be collected from venipuncture in order to evaluate MMPs (and other related molecules) plasma levels. These data will be related to clinical findings.

Interventions

PROCEDUREBlood drawing (venipuncture)

Patients with Deep Vein Thrombosis will undergo blood drawing in order to collect plasma samples.

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Acute DVT of lower limbs. * no known prior history of DVT * availability to make follow-up appointments.

Exclusion criteria

* prior history of DVT * neoplasia * arterial aneurysms * venous ulcers

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of plasma MMPs levels36 monthsMMPs plasma levels and other related molecules (TIMPS, NGAL and cytokines) will be evaluated during follow up.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026