PROLONG-II Study

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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)

Objective

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

Sponsor

St. Orsola Hospital

Timeline

Timeline
Start Date	August 2005
End Date	June 2008
Status	Completed

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00266045

Study Description

Study Description
Study Type	Observational
Study Design	Observational Model: Cohort Time Perspective: Prospective
Study Details
Condition	Deep Vein Thrombosis Pulmonary Embolism
Population Size	355

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00266045.

Eligibility Criteria

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