A Pilot Study in Feasibility and Safety: Point of Care Testing With Thromboelastography (TEG) for Blood Product Transfusion in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time
研究概览
简要总结
This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG algorithm in addition to traditional laboratory tests to guide transfusion and coagulation management of ECMO patients.
详细描述
All adult patients requiring ECMO will be considered for the trial, with a target enrollment of 50 participants over a two-year period. For each enrolled participant, a TEG transfusion algorithm will be followed for patients exhibiting inadequate hemostasis in the operating room (Flowchart 1). Once patient has a normal TEG result with adequate hemostasis, either heparin or bivalirudin will be used as the anticoagulant. If patients are receiving no anticoagulation or heparin anticoagulation then a second TEG algorithm will be followed in the ICU when hemostasis is normal and heparin is introduced (Flowchart 2). If patients are receiving bivalirudin as their anticoagulation strategy, the transfusion parameters with TEG application will not apply. In addition to determining the compliance and feasibility of following these TEG algorithms, clinical outcome data including transfusion rates, types of blood products transfused, estimated blood loss and thrombotic events will be collected for every enrolled patient until they are discontinued from ECMO. Statistical analysis of the primary, secondary and tertiary endpoints of this study will determine the likelihood of exploring future clinical trials involving TEG-driven coagulation and transfusion management of the ECMO population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient's requiring ECMO placement
排除标准
- •Other than children less than 18 years of age, no one will be excluded.
结局指标
主要结局
Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time
时间窗: From time patient is placed on ECMO to 30-days post ECMO initiation
次要结局
- Number of Transfusions Required While on ECMO(From the time patient is placed on ECMO to 30-days post ECMO initiation)
- Type of Blood Products Transfused(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Pump Exchanges Required(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Oxygenator Exchanges(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Time to Weaning From/Removal of ECMO(From time patient is placed on ECMO until time to weaning from ECMO)
- Need for Surgical Intervention for Hemorrhage(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus(From the time patient is placed on ECMO to 30-days post ECMO initiation)
- Chest Tube Output and Overall Estimated Blood Loss(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Time Between Transfusions(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange)(From time patient is placed on ECMO to 30-days post ECMO initiation)
- Specimen Turn Around Time for Lab Tests (CBC, ACT, PT, PTT, Anti-Xa, INR, Platelet Count) and TEG Results(From time patient is placed on ECMO to 30-days post ECMO initiation)
研究者
Stephen Esper
Assistant Professor of Anesthesiology, Chief of Perioperative Services
University of Pittsburgh