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

Primary Purpose

Venous Thromboembolism

Status

Terminated

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Warfarin

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring D-dimer, Recurrence, Venous thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Of Insubria

Outcomes

Primary Outcome Measures

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

Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations

Secondary Outcome Measures

Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy

Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy

Mortality

Full Information

NCT ID

NCT00428441

First Posted

January 26, 2007

Last Updated

August 18, 2011

Sponsor

Università degli Studi dell'Insubria

1. Study Identification

Unique Protocol Identification Number

NCT00428441

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Terminated

Why Stopped

Enrolment was halted prematurely because of the observed excess in recurrences

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism

Keywords

D-dimer, Recurrence, Venous thromboembolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Warfarin

Intervention Description

tablets, based on INR levels, according to D-dimer levels

Primary Outcome Measure Information:

Title

Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels

Description

Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis

Time Frame

1 year

Title

Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy

Time Frame

3 months

Title

Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy

Time Frame

3 months

Title

Mortality

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gualtiero Palareti

Organizational Affiliation

University of Bologna

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Walter Ageno

Organizational Affiliation

Università degli Studi dell'Insubria

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Vittorio Pengo

Organizational Affiliation

University of Padova

Official's Role

Study Director

Facility Information:

Facility Name

University Of Insubria

City

Varese

ZIP/Postal Code

21100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

17065639

Citation

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. doi: 10.1056/NEJMoa054444. Erratum In: N Engl J Med. 2006 Dec 28;355(26):2797.

Results Reference

background

PubMed Identifier

11848459

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.

Results Reference

background

Learn more about this trial

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

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