ECMO Hemostatic Transfusions in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Total Platelet Transfusion Dose
研究概览
简要总结
Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. The ECmo hemoSTAtic Transfusions In Children (ECSTATIC) pilot trial will test two different platelet transfusion strategies, based on two different platelet counts thresholds, one high (higher platelet transfusion strategy) and one low (lower platelet transfusion strategy). The pilot will gather the necessary information to perform a full trial which will provide a better understanding of how to transfuse platelets to children supported by ECMO and reduce the associated morbidity.
详细描述
Due to coagulopathy and thrombocytopenia induced by hemodilution and the extracorporeal circuit itself, children supported by extracorporeal membrane oxygenation (ECMO) are at significant risk of bleeding. In order to prevent bleeding, pediatric intensivists often prescribe prophylactic platelet transfusions. However, in observational studies, prophylactic platelet transfusions to children on ECMO have been independently associated with increased thrombosis, mortality, and paradoxically, increased bleeding. Guidelines to direct platelet transfusions in this patient population are limited by the lack of evidence and therefore based on expert opinion alone. Given the significant associated risks, it is crucial to provide evidence to guide clinicians.
The ECSTATIC pilot, a randomized controlled trial endorsed by BloodNet, PediECMO, the Extracorporeal Life Support Organization (ELSO), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), will be conducted in ten sites (9 in the US and 1 in Israel). The investigators will enroll an anticipated 50 consecutive critically ill children (0 to <18 years of age), admitted to a participating pediatric, neonatal, or cardiac intensive care unit (PICU/NICU/CICU), on ECMO, and who have either no bleeding or minimal bleeding.
Non-bleeding children 0 to less than 18 years of age will be randomized 1:1 to either a platelet transfusion threshold of 90 x10e9/L (higher platelet transfusion strategy) or 50 x10e9/L (lower platelet transfusion strategy). Participants will be followed until progression to severe bleeding and/or severe thrombosis, decannulation from ECMO, or reach 21 days.
In this pilot, the investigators will test the separation between the lower and higher transfusion strategies. The primary outcomes will be the separation between pre-transfusion platelet counts, and the total platelet dose (in mL/kg/run). Secondary outcomes will be feasibility of patient enrollment and ability for an adjudication committee to determine the severity of bleeding and thrombotic outcomes.
The purpose of this pilot study is to determine the feasibility of the transfusion strategies, intervention parameters, subject availability, and other information regarding outcomes that are essential to complete the design of a large randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and Outcome Assessors will be masked to the intervention, but the clinical team at the bedside will need to know the allocation to be able to prescribe platelet transfusion according to the randomized threshold.
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill children (0 to <18 years of age)
- •Admitted to a participating pediatric, neonatal, or cardiac intensive care unite (PICU/NICU/CICU)
- •On extracorporeal Membrane Oxygenation (ECMO)
- •Who have either no bleeding or minimal bleeding, within 24 hours of cannulation. Minimal bleeding is defined as:
- •streaks of blood in endotracheal tube or during suctioning only
- •streaks of blood in nasogastric tube
- •macroscopic hematuria
- •subcutaneous bleeding (including hematoma and petechiae) < 5 cm in diameter
- •quantifiable bleeding < 1mL/kg/hr (e.g., chest tube)
- •bloody dressings required to be changed no more often than each 6hr, or weighing no more than 1mL/kg/hr if weighed, due to slow saturation
排除标准
- •Post-conception age < 37 weeks at time of screening
- •Underlying oncologic diagnosis (defined as receipt of chemotherapy or radiation in the last six months) or recipient of bone marrow transplant in the last year
- •Congenital bleeding disorder
- •Pregnant or admitted post-partum
- •Decision to withdraw or withhold some critical care or interventions
- •Known objection to blood transfusions
- •On ECMO for > 24 hours at time of enrollment
研究组 & 干预措施
Higher platelet transfusion strategy
Participants randomized to this arm will be transfused if the platelet count is < 90 x 10e9 cells/L.
干预措施: Platelet Transfusion (Biological)
Lower platelet transfusion strategy
Participants randomized to this arm will be transfused if the platelet count is < 50 x 10e9 cells/L.
干预措施: Platelet Transfusion (Biological)
结局指标
主要结局
Total Platelet Transfusion Dose
时间窗: up to day 21
The total dose (in mL/kg/day) will be computed by the research team, by dividing the total platelet transfusion volume by the patient's weight at admission and the number of days of intervention.
Pre-transfusion Platelet Count
时间窗: During intervention
Pre-transfusion platelet count, during intervention
次要结局
- Feasibility Assessed by the Screening Rate(At screening)
- Feasibility Assessed by the Inclusion Rate(At screening)
- Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation.(At screening)
- Compliance With Transfusion Thresholds(up to Day 21)
- Participants With at Least One Temporary Suspension(up to Day 21)
- Duration for Temporary Suspensions(up to Day 21)
- Progression to Composite Outcome of Severe Bleeding and/or Severe Thrombotic Event(up to Day 21)
- Number of Participants Who Were Withdrawn and/or Lost to Follow-up(Up to 90 days)