Venous Thromboembolism
Conditions
Keywords
D-dimer, Recurrence, Venous thromboembolism
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.
Interventions
DRUGWarfarin
tablets, based on INR levels, according to D-dimer levels
Sponsors
Università degli Studi dell'Insubria
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels | 1 year | Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis |
| Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations | 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy | 3 months |
| Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy | 3 months |
| Mortality | 3 months |
Countries
Italy
Participant flow
Recruitment details
recruitment period 2007-2009 location Thrombosis centers
Participants by arm
| Arm | Count |
|---|---|
| D-dimer Negative patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | D-dimer Negative |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age Continuous | 61.9 years STANDARD_DEVIATION 14 |
| Region of Enrollment Italy | 75 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations
Time frame: 3 months
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
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D-dimer Negative | Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels | 9 participants |
Secondary
Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy
Time frame: 3 months
Secondary
Mortality
Time frame: 3 months
Secondary
Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy
Time frame: 3 months