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临床试验/NCT04912336
NCT04912336已完成不适用

Extra Corporeal Life Support and Modification of Hemostasis

University Hospital, Ghent6 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2021年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
6
主要终点
Thrombocytopenia

研究概览

简要总结

To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO.

(ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO).

详细描述

This is a multi-center, prospective, pilot cohort study, performed in the Intensive Care Units (ICUs) of the Ghent University Hospital, CHU Liège, University Hospital Brussels, and University Hospital Munster.

Each group will contain 20 subjects; in total there will be 40 subjects 2 groups of 20 patients GROUP 1: VV-ECMO n = 20 GROUP 2: VA-ECMO n = 20

  • Demographics: age, sex, comorbidities, medication, reason for ECMO therapy

  • Simplified Acute Physiology Score (SAPS) 3 at time of ICU admission.

  • Components of the Sequential Organ Failure Assessment score daily (based on worst value of each component of the score)

  • ECMO characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations)

  • Incidence and severity of bleeding, scored according to the GUSTO and BARC scores

  • Coagulation profile: At inclusion (before heparine infusion is started), 2h after start of therapy, 24h, and 48h, and at specific moments of clinical suspicion of profound altered hemostasis. We defined a coagulation profile as a set of tests that includes

  • prothrombin time (PT), international normalized ratio (INR)

  • activated partial thromboplastin time (aPTT) and heparin ratio

  • the fibrinogen level

  • platelets

  • ACT (iACT®, ...)

  • D-dimer

  • ROTEM (extem, intem, heptem) or TEG (Utrecht)

  • AT III

  • anti Xa

  • Temperature daily (H/L) (core)

  • Patient characteristics that may influence coagulation or the results of coagulation tests: body weight, Body Mass Index, drugs, C-reactive protein (as a marker for inflammation), Hemoglobin level, LDH, unconjugated bilirubin, (or haptoglobine or plasma free haemoglobin, if tested)

  • Heparin dose

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period
  • GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
  • ≥ 18 years
  • Signed Informed Consent, signed by subject or authorized representative
  • Exclusion criteria:
  • Expected survival <48-h Known coagulopathy Pregnancy

排除标准

  • 未提供

结局指标

主要结局

Thrombocytopenia

时间窗: 48 hours

Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients

次要结局

  • Change in visco-elastic testing(At 2 hours, 24 hours, 48 hours)
  • Survival(1 year)
  • Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria(48 hours)
  • Clotting problems(48 hours)
  • Need for transfusion(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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