D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00264277
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis; Pulmonary Embolism	Drug: Vitamin K antagonist (Coumarin anticoagulants)	Phase 4

Detailed Description

This is a multicenter prospective follow-up study in patients with a first episode of symptomatic idiopathic venous thromboembolism (proximal deep vein thrombosis and/or pulmonary embolism) who are treated with vitamin K antagonists (either warfarin or acenocoumarol) for a minimum of 3 months. Eligible patients who give informed consent are instructed to immediately stop oral anticoagulation and refrain from taking any other antithrombotic drugs until the next visit, scheduled after 30 days. At that visit, venous blood is sampled to perform D-dimer assay and thrombophilia tests. D-dimers are assessed using the Clearview Simplify D-dimer assay (Agen Biomedical Limited, Brisbane, Australia). Patients with normal D-dimer results do not continue anticoagulation, whereas those with elevated D-dimer results are randomized using a computer program to either stop or resume anticoagulation with vitamin K antagonists (INR 2.0-3.0). All patients are followed-up for 18 months. The study outcome are the composite of confirmed recurrent venous thromboembolism and major bleeding events. All suspected outcome events and all deaths are evaluated by a central adjudication committee whose members are unaware of the D-dimer and thrombophilia results and of the group assignments.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: D-dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized "Prolong" Study
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Dec 1, 2004
• Actual Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up []

2. Confirmed major bleeding events at 18 months follow up []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years

• After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism

• After at least 3 months of oral anticoagulation

• After written informed consent

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi	Bologna	BO	Italy	40138

Sponsors and Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

• Study Chair: GUALTIERO PALARETI, MD, Head of Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

• Eichinger S, Minar E, Bialonczyk C, Hirschl M, Quehenberger P, Schneider B, Weltermann A, Wagner O, Kyrle PA. D-dimer levels and risk of recurrent venous thromboembolism. JAMA. 2003 Aug 27;290(8):1071-4.
• Palareti G, Legnani C, Cosmi B, Guazzaloca G, Pancani C, Coccheri S. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost. 2002 Jan;87(1):7-12.
• Palareti G, Legnani C, Cosmi B, Valdré L, Lunghi B, Bernardi F, Coccheri S. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation. 2003 Jul 22;108(3):313-8. Epub 2003 Jul 7.

• Responsible Party: GUALTIERO PALARETI, Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna
• ClinicalTrials.gov Identifier: NCT00264277
• Other Study ID Numbers: PROLONG STUDY
• First Posted: Dec 12, 2005
• Last Update Posted: Mar 19, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by GUALTIERO PALARETI, Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna: D-dimer; Recurrence; Venous Thromboembolism; Anticoagulation; Duration
• Additional relevant MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Vitamin K; Anticoagulants

Study Results

No Results Posted as of Mar 19, 2021