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临床试验/NL-OMON52728
NL-OMON52728招募中3 期

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

eids Universitair Medisch Centrum0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • * 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

排除标准

  • * 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

研究者

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