Extra Corporeal Life Support and Modification of Hemostasis
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
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Demographics: age, sex, comorbidities, medication, reason for ECMO therapy
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Simplified Acute Physiology Score (SAPS) 3 at time of ICU admission.
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Components of the Sequential Organ Failure Assessment score daily (based on worst value of each component of the score)
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ECMO characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations)
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Incidence and severity of bleeding, scored according to the GUSTO and BARC scores
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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
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prothrombin time (PT), international normalized ratio (INR)
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activated partial thromboplastin time (aPTT) and heparin ratio
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the fibrinogen level
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platelets
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ACT (iACT®, ...)
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D-dimer
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ROTEM (extem, intem, heptem) or TEG (Utrecht)
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AT III
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anti Xa
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Temperature daily (H/L) (core)
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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)
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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
- 否
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)
