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

Pulmonary Embolism Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266045
• Other study ID #: PROLONG-TWO STUDY
• Status: Completed
• Start date: August 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Recurrence
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
Italy	Dept. Angiology & Blood Coagulation; Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi	Bologna	BO

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Italian Federation of Anticoagulation Clinics (FCSA)

Country where clinical trial is conducted

Italy,