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Advanced diagnostic management of suspected recurrent ipsilateral deep vein thrombosis of the leg with magnetic resonance direct thrombus imaging - The Theia study

Phase 4
Completed
Conditions
Deep vein thrombosis
venous thrombosis
10064477
Registration Number
NL-OMON45235
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
305
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

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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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