D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Official title:

The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00428441
• Other study ID #: 2175
• Status: Terminated
• Phase: N/A
• First received: January 26, 2007
• Last updated: August 18, 2011
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low.

The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels.

Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: May 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)

• Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases

• Age > 18 years

• Informed consent provided

Exclusion Criteria:

• Pregnancy/puerperium

• One or more episodes of massive pulmonary embolism

• Last event isolated idiopathic pulmonary embolism

• Two or more idiopathic VTE events

• First degree relatives with recurrent VTE

• Right ventricular disfunction or pulmonary hypertension

• Active cancer

• Antiphospholipid antibodies syndrome

• Antithrombin deficiency

• Homozygous Factor V Leiden or G20210A prothrombin mutation

• Heterozygous Factor V Leiden and G20210A prothrombin mutation

• Concomitant congenital thrombophilic mutations

• Concomitant indications to long term oral anticoagulant treatment

• Severe cardiorespiratory insufficiency

• Severe liver or renal disease (creatinine clearance > 2 mg/dL)

• Limited life expectancy

• Geographic inaccessibility

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Warfarin
tablets, based on INR levels, according to D-dimer levels

Locations

Country	Name	City	State
Italy	University Of Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Palareti G, Cosmi B, Legnani C, Tosetto A, Brusi C, Iorio A, Pengo V, Ghirarduzzi A, Pattacini C, Testa S, Lensing AW, Tripodi A; PROLONG Investigators. D-dimer testing to determine the duration of anticoagulation therapy. N Engl J Med. 2006 Oct 26;355(17):1780-9. Erratum in: N Engl J Med. 2006 Dec 28;355(26):2797. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels	Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis	1 year	No
Primary	Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations		3 months	No
Secondary	Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy		3 months	Yes
Secondary	Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy		3 months	Yes
Secondary	Mortality		3 months	Yes