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临床试验/EUCTR2018-003564-31-DK
EUCTR2018-003564-31-DK进行中(未招募)1 期

ow dose catheter directed thrombolysis for acute intermediary-high risk pulmonary embolism. - BETULA

Aarhus University Hospital0 个研究点目标入组 60 人开始时间: 2019年2月27日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Age > 17 and < 81 years
  • - Debut of symptoms <14 days
  • - Acute symptomatic Intermediate-high risk PE (according to 2014 ESC guidelines) confirmed by CTA with the embolus located in at least one proximal lower lobe or main pulmonary artery.
  • - Right-to-left ventricular dimension ratio >1.0 on contrast enhanced computed tomography or transthoracic echocardiography.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 40

排除标准

  • - Significant bleeding risk or other contraindications to catheter directed trombolysis or unfractioned heparin.*
  • - Not possible to perform catheter directed trombolysis within 48 h after diagnosis
  • - Known pregnancy or positive urine hCG screening test in fertile women**
  • - Cardiac arrest requiring cardiopulmonary resuscitation
  • - Life expectancy < 120 days
  • - Altered mental status such that the patient is unable to provide informed consent
  • - Chronic thromboembolic pulmonary hypertension
  • - Sustained hypertension (>180 mmHg systolic and/or >105 mmHg diastolic)
  • *Treated with thrombolytics for the index
  • ** Fertile women will be screened for pregnancy with a blood hCG screening test before inclusion if they are not on any contraceptives.

研究者

发起方
Aarhus University Hospital

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