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

NCT00266045 | Completed

• 1 other identifier: PROLONG-TWO STUDY
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Keywords

Deep Vein Thrombosis; Pulmonary Embolism; D-dimer; Recurrence; Duration of Anticoagulation; Vitamin K Antagonists

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with a single previous idiopathic venous thromboembolic event who stop anticoagulation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Italian Federation of Anticoagulation Clinics (FCSA): collaborator

Study Sites (1)

Dept. Angiology & Blood Coagulation; Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

Related Publications (3)

• Cosmi B, Legnani C, Pengo V, Ghirarduzzi A, Testa S, Poli D, Prisco D, Tripodi A, Palareti G; PROLONG Investigators (on behalf of FCSA, Italian Federation of Anticoagulation Clinics). The influence of factor V Leiden and G20210A prothrombin mutation on the presence of residual vein obstruction after idiopathic deep-vein thrombosis of the lower limbs. Thromb Haemost. 2013 Mar;109(3):510-6. doi: 10.1160/TH12-01-0041. Epub 2013 Jan 10.

  PMID: 23306310 DERIVED

• Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Marongiu F, Palareti G; PROLONG Investigators (on behalf of Italian Federation of Anticoagulation Clinics). Usefulness of repeated D-dimer testing after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the PROLONG II prospective study. Blood. 2010 Jan 21;115(3):481-8. doi: 10.1182/blood-2009-08-237354. Epub 2009 Nov 16.

  PMID: 19965693 DERIVED

• Palareti G, Cosmi B, Legnani C. D-dimer testing to determine the duration of anticoagulant therapy. Curr Opin Pulm Med. 2007 Sep;13(5):393-7. doi: 10.1097/MCP.0b013e3282058b94.

  PMID: 17940483 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples for D-dimer assays or other coagulation tests

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Recurrence

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gualtiero Palareti, MD

  Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Gualtiero Palareti

Study Record Dates

• First Submitted: December 13, 2005
• First Posted: December 15, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

IT (1)