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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00266045
Enrollment
355
Registered
2005-12-15
Start date
2005-08-31
Completion date
2008-12-31
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Pulmonary Embolism

Keywords

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

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026