跳至主要内容
临床试验/NCT01903863
NCT01903863已完成不适用

Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.

Duke University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
ECMO Pump Longevity

研究概览

简要总结

The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients < 18 years receiving ECMO

排除标准

  • Planned withdrawal of life sustaining therapy in the next 48 hours
  • Previous enrollment in the study
  • Patients who cannot be consented within 48 hours
  • Pregnant patients

结局指标

主要结局

ECMO Pump Longevity

时间窗: ECMO course (median 198 hours)

The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours

次要结局

  • Red Blood Cell Transfusion(ECMO course (median 198 hours))
  • Platelets Transfusion Requirement(ECMO course (median 198 hours))
  • Hemorrhagic and Thrombotic Complications(ECMO course (median 198 hours))
  • Antithrombin Levels(ECMO course (median 198 hours))
  • Plasma Free Hemoglobin(ECMO course (median 198 hours))
  • Time to Therapeutic aPTT(ECMO course (median 198 hours))
  • Fresh Frozen Plasma Transfusion Requirements(ECMO course (median 198 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验