NL-OMON20771Not yet recruitingNot Applicable
Magnetic Resonance Direct Thrombus Imaging for diagnostic management of suspected pelvic vein thrombosis during pregnancy
.A.0 sites150 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •?Pregnant women with suspected DVT, defined as i) new leg swelling or edema with onset in the last month or ii) new leg pain (buttock, groin, thigh or calf) with onset in the last month; pregnancy is defined as a positive pregnancy test and no sign of miscarriage
- •?Onset of symptoms more than 24 hours but less than 10 days ago
- •?Aged 18 years or older
- •?Willing and able to give written informed consent
Exclusion Criteria
- •?Concomitant symptoms of suspected PE (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia)
- •?Therapeutic anticoagulant therapy more than 48 hours prior to inclusion (thrombosis prophylaxis is allowed)
- •?MRI contra-indication (including but not limited to a cardiac pacemaker or subcutaneous defibrillator; vascular clips in the cerebral vessels; metal splinter in the eye, a hearing aid that cannot be removed; a neurostimulator that cannot be removed; a hydrocephalus pump; claustrophobia)
- •?Unable to perform MRI within 48 hours
- •?A medical condition, associated illness or co-morbid circumstances that precludes completion of the study procedures (MRI and 90-day follow-up assessment), including but not limited to life-expectancy less than 3 months, inability to lie flat or morbid obesity preventing use of MR.
- •?Any reperfusion therapy (e.g. thrombolysis, surgical clot removal) initiated for the current suspected VTE diagnosis applied before subjecting the patient to MRDTI.
Investigators
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