D-dimer Levels During and After Anticoagulation in Patients With a Previous Venous Thromboembolism: Effects on the Risk of Recurrence

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT00266045

Collaborator

Italian Federation of Anticoagulation Clinics (FCSA) (Other)

355

Enrollment

Location

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing significantly this rate. Those patients with normal D-dimer (about 60% of all patients examined) have a low rate of recurrences (about 5%) and likely a prolongation of anticoagulation in all these patients cannot be recommended.

In line with these results, the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up.

Patients with a first unprovoked venous thromboembolism (including proximal deep vein thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists for not less than 6 months are considered for the study. D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later. Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay. The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis Pulmonary Embolism

Study Design

Study Type:

Observational

Actual Enrollment :

355 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicentre, Prospective, Observational Study on the Predictive Role for Recurrence of D-dimer Levels Measured During and After Anticoagulation in Patients With a First Venous Thromboembolism Episode (the PROLONG-II Study)

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 82 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Age > 18 years
After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
After at least 6 months of oral anticoagulation
After written informed consent

Exclusion Criteria:

Age > 82 y
Recurrent venous thromboembolism
If the Venous thromboembolism occurred:
during pregnancy or puerperium
after recent (i.e. within three months) fracture or plaster casting of a leg,
after immobilization with confinement to bed for three consecutive days after surgery with general anesthesia lasting longer than 30 minutes
Patients with:
active cancer
antiphospholipid antibody syndrome
antithrombin deficiency
serious liver disease or renal insufficiency (creatininemia > 2 mg/dL),
other indications for anticoagulation or contraindications for this treatment
limited life expectation
Patients who live too far from the clinical center