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临床试验/DRKS00033769
DRKS00033769招募中不适用

nderstanding Extracorporal Membrane Oxygenation Induced Coaguloapathy – A Prospective Cohort Study in the Intensive Care Unit (EXTRICATE) - EXTRICATE

niversität Witten/Herdecke & Klinik Köln Merheim0 个研究点目标入组 50 人开始时间: 2024年2月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • For VV-ECMO analogous to previous studies:
  • - severe ARDS according to the Berlin criteria
  • - PaO2:FiO2 ratio <50 mmHg for >3 hours despite optimization of mechanical ventilation [FiO2 =80%, tidal volume = 6 ml per kg of ideal body weight and positive end-expiratory pressure (PEEP) =10 cm H2O) and despite the use of adjuvant therapeutic measures (e.g. inhaled nitric oxide therapy, recruitment maneuver, ventilation in prone position)]
  • - PaO2:FIO2 ratio <80 mmHg for >6 hours despite the aforementioned measures
  • - Arterial pH <7.25 with PaCO2 >60 mmHg for >6 hours under ventilator settings with a plateau pressure =32 cm H2O
  • For VA-ECMO analogous to previous studies:
  • - Observed collapse with no-flow time < 5 min and low-flow time < 90 min on arrival in the cardiac catheter
  • - Initial and sustained defibrillable rhythm or non-defibrillable rhythm in case of tamponade or pulmonary artery embolism (exception: accidental hypothermia or intoxication)

排除标准

  • 1. pregnancy
  • 2. patient moribund or with Simplified Acute Physiology Score value >90
  • 3. underlying malignancy with life expectancy < 5 years
  • 4. irreversible neurological damage
  • 5. decision to limit therapy
  • 6. ventilation for longer than 7 days (for vv-ECMO)
  • 7. chronic lung disease and chronic respiratory respiratory insufficiency with home oxygen therapy (for vv-ECMO)
  • 8. history of heparin-induced thrombocytopenia or other contraindication to heparin
  • 9. hereditary thrombophilia or hemophilia
  • 10. therapeutic anticoagulation or dual platelet inhibition

研究者

发起方
niversität Witten/Herdecke & Klinik Köln Merheim

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