NCT02376764

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Status
completed

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 Start

First participant enrolled

February 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

2.9 years

First QC Date

February 25, 2015

Last Update Submit

March 2, 2015

Conditions

Postthrombotic Syndrome With Ulcer of Left Lower ExtremityExtracellular Matrix Alteration

Outcome Measures

Primary Outcomes (1)

  • Evaluation of plasma MMPs levels

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

    36 months

Interventions

Blood drawing (venipuncture)PROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Deep Vein Thrombosis of lower limbs during their first episode.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Blood Specimen CollectionPhlebotomy

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Raffaele Serra

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 3, 2015

Study Start

February 1, 2012

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

March 3, 2015

Record last verified: 2015-03