Deep vein thrombosis venous thrombosis
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1 Ability of subject to understand the character and individual consequences of this study; 2 Signed and dated informed consent of the subject available before the start of any specific study procedures; 3 Age >=18 years; 4 Suspected acute recurrent ipsilateral DVT, as defined by a documented prior objectivated episode of DVT in the same leg as current symptoms originate from
Exclusion criteria
Exclusion criteria: 1 General contraindications for MRI: claustrophobia, first trimester of pregnancy, intracranial vascular clips, any ferromagnetic implants, presence of a cardiac pacemaker or defibrillator, metallic splinters in the eye, any trauma or surgery which may have left ferromagnetic material in the body; 2 CUS-proven acute symptomatic DVT within 6 months before current presentation; 3 Onset of symptoms suggestive of acute recurrent DVT more than 10 days prior to presentation; 4 Suspected acute PE; 5 Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise); 6 Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months 8 Non-compliance or inability to adhere to treatment or follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the 3-month incidence of recurrent VTE in patients with MRDTI that is negative for the presence of DVT. The primary sensitivity analysis is restricted to patients who did not receive anticoagulants in the follow-up period. Symptomatic DVT of both the ipsilateral as contralateral leg is defined as symptoms suggestive of acute DVT, i.e. ongoing pain, swelling, tenderness, warmth and/or erythema of the leg of recent onset, and non-compressibility of the common femoral and/or popliteal vein in a new venous segment, or a pronounced increase in vein diameter (>= 4 mm) of a previously uncompressible vein as compared to the reference CUS performed at baseline. Acute PE is defined as at least one filling defect in the pulmonary artery tree on CTPA. In addition, PE is considered as the cause of any unexplained death unless autopsy will prove otherwise. All primary endpoints will be adjudicated by an independent Clinical Events Committee (see section on Monitoring). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include: 1 Post-hoc assessment of the 3-month incidence of recurrent VTE after the baseline combination of a normal D-dimer test (for patients aged over 50 years age x 10 µg/l, for patients aged 50 years or younger 500 µg/l), and an unlikely ruling by the Wells score for DVT (Appendix B). The golden standard for a correct negative ruling by the D-dimer test and the clinical decision rule is a normal MRDTI at baseline and an uneventful 3-month follow-up period; 2 Feasibility of MRDTI as diagnostic test in daily clinical practice, i.e. the number of patients that could not be managed according to the study protocol due to logistical or technical issues and the mean time from presentation to MRDTI ruling; 3 Post-hoc assessment of the inter-observer variability of MRDTI in clinical practice: 100 MRDTI scans (first 10 scans of each study site) will be re-assessed after the study by 2 independent radiologists, who are blinded tot the clinical presentation and follow-up of the study patients. Their ruling will be compared to the ruling of the attending radiologist at the moment of clinical presentation; 4 A cost-effectiveness (KEA) and cost-utility analysis (KUA). Both will be dependent on data derived from this study as well as data from the literature. The KEA will provide en estimation of the total costs associated with diagnostic tests for one prevented false-positive diagnosis. The KUA will be additionally be based on estimated costs for patient monitoring, bleeding complications and productivity costs. Assessment of quality-adjusted life-years (QALY) after a MRDTI based diagnostic strategy will be compared to a CUS-bases strategy, using cost-utility models as proposed by the British National Institute for Health and Clinical Excellence (NICE), specified for Dutch norms | — |
Countries
Netherlands
Outcome results
None listed