NCT04625764终止不适用
A Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent Cardiothoracic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 8
- 主要终点
- Platelet reactivity
研究概览
简要总结
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed informed consent
- •Males and females aged ≥18 years
- •Patients treated with ticagrelor
- •Emergency Coronary Artery Bypass Graft (CABG) surgery
- •Cardiothoracic surgery requiring CPB ≤24 hours following the last dose of ticagrelor
排除标准
- •Any cardiothoracic surgery >24 hours after last dose of ticagrelor
- •Resuscitation
- •Any pre-operative coagulopathy unrelated to ticagrelor or standard of care (SoC) to undergo surgery with CPB
- •Sepsis (according to Sepsis 3.0 definition)
- •Malignant tumor
- •Left ventricular ejection fraction (LVEF) < 20%
- •History or presence of significant pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurologic, or psychiatric disease which, in the opinion of the Investigator, increases risk to the patient or could confound the results of the study
- •Presence of end-stage renal disease or currently receiving renal replacement therapy
- •Patients with a history of major organ transplantation
- •Patients in acute sickle cell crisis
- •Patients concurrently requiring immunosuppressive therapy, with the exception of corticosteroids, or who are profoundly immune suppressed (e.g. CD4 < 200 or neutropenia with ANC < 1000/μL)
- •Women of childbearing potential with a positive pregnancy test performed during the current admission or who are lactating. Women are considered not of child bearing potential if they have been sterilized at least 6 months prior to the study or if they are post-menopausal, defined as amenorrhea for at least 12 months
结局指标
主要结局
Platelet reactivity
时间窗: 8 hours
Proportion of patients with post-operative platelet reactivity to ADP above the level associated with increased bleeding risk (≥ 22 ADP-induced platelet aggregation units (AUC in units)) measured on the MEA platform immediately after CPB compared to immediately before CPB.
次要结局
未报告次要终点
研究者
研究点 (8)
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