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

Phase 3

Recruiting

• Conditions: Thrombosis; 10064477; 10026908

• Registration Number: NL-OMON52728
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 90

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
<p>Zie protocol, hoofdstuk 3 (Objectives)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Zie protocol, hoofdstuk 3 (Objectives)</p><br>