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Completed

NCT Number: NCT02376764

Biomarkers in Post Thrombotic Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood drawing (venipuncture)

Procedure

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

Primary outcomes

  1. Evaluation of plasma MMPs levels

    Time frame: 36 months

    MMPs plasma levels and other related molecules (TIMPS, NGAL and cytokines) will be evaluated during follow up.

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

New Biomarkers in Post Thrombotic Syndrome

Acronym: BIPOSTO

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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