Magnetic Resonance Direct Thrombus Imaging for diagnostic management of suspected pelvic vein thrombosis during pregnancy

Conditions: Deep vein thrombosis

Registration Number: NL-OMON20771

Lead Sponsor: .A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of positive MRDTI findings in pregnant women with suspected pelvic vein thrombosis but negative single CUS (efficiency outcome).

Secondary Outcome Measures

Name	Time	Method
1.Number of VTE events occurring in pregnant women with suspected pelvic vein thrombosis who remained untreated based on a normal MRDTI result (safety outcome). <br>2.Number of VTE events occurring in pregnant women in whom DVT is ruled out by combination of LEFt criteria and D-dimer test (safety outcome).<br>3.Number of patients with 0-1 LEFt criteria and a normal D-dimer test (efficiency outcome).<br>4.Frequency of positive MRDTI findings in patients with suspected DVT during pregnancy in whom this diagnosis was ruled out by combination of LEFt criteria and D-dimer test.<br>5.Kappa-statistic of the combined MRDTI reading from both study cohorts between 2 experienced radiologists (post-hoc).