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Sponsors and Collaborators: |
St. Orsola Hospital Italian Federation of Anticoagulation Clinics (FCSA) |
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Information provided by: | St. Orsola Hospital |
ClinicalTrials.gov Identifier: | NCT00266045 |
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.
Study Type: | Observational |
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) |
Ages Eligible for Study: | 18 Years to 82 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Contact: Gualtiero Palareti, MD | + 39 051 6362111 ext 2483 | palareti@tin.it |
Contact: Benilde Cosmi, MD PhD | + 39 051 6362111 ext 2790 | bcosmi@med.unibo.it |
Italy, BO | |
Dept. Angiology & Blood Coagulation; Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi | Recruiting |
Bologna, BO, Italy, 40138 | |
Contact: Gualtiero Palareti, MD + 39 051 6362111 ext 2483 palareti@tin.it | |
Principal Investigator: Benilde Cosmi, MD PhD |
Study Chair: | Gualtiero Palareti, MD | Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna |
Study ID Numbers: | PROLONG-TWO STUDY |
Study First Received: | December 13, 2005 |
Last Updated: | December 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00266045 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Deep Vein Thrombosis Pulmonary Embolism D-dimer |
Recurrence Duration of Anticoagulation Vitamin K Antagonists |
Pulmonary Embolism Vascular Diseases Fibrin fragment D Venous Thromboembolism Thrombosis Thromboembolism Recurrence |
Embolism and Thrombosis Respiratory Tract Diseases Embolism Lung Diseases Vitamins Vitamin K Venous Thrombosis |
Disease Attributes Pulmonary Embolism Vascular Diseases Venous Thromboembolism Recurrence Thromboembolism Thrombosis |
Embolism and Thrombosis Pathologic Processes Respiratory Tract Diseases Embolism Lung Diseases Venous Thrombosis Cardiovascular Diseases |