Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.
研究概览
简要总结
This is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an extended panel of coagulation and metabolic blood tests with the aim of early warning of impending bleeding to allow intervention in the form of adjusted bivalirudin dose, modification of other risk factors, or transfusion with hemostatic products targeted to documented coagulation test abnormalities.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure. Surgical and non-surgical patients will be included.
排除标准
- •known pre-existing bleeding disorder (due to a factor deficiency that requires factor replacement, or platelet disorder), or a creatinine > 2.0.
结局指标
主要结局
Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.
时间窗: Up to 2 weeks
To determine if changes over time in an extended blood panel (EBP) and metabolic panel (MP) could provide early warning of impending bleeding in patients on ECMO. The extended blood panel includes: Dilute thrombin time (DTT), Factor XIII, Factor VIII, Factor IX, and Von Willebrand Disease (VWD) panel, and Factor XI, Factor X, Factor VII, Factor V, Factor II, protein C, protein S, thromboelastogram (TEG), and TEG-platelet mapping).
次要结局
- Number of participants designated as non-major bleeders (NMB)(Up to 2 weeks)
- Number of participants designated as major bleeders (MB)(Up to 2 weeks)