A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect of plasmapheresis replacement fluid type on fibrinogen level
研究概览
简要总结
Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana
排除标准
- •pregnancy
- •coagulation disorders
- •Hypertriglyceridemia-induced acute pancreatitis
- •hepatic disorders
研究组 & 干预措施
Fibrinogen Treatment Group
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards.
干预措施: Fibrinogen concentrate (Drug)
FFP Treatment Group
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.
干预措施: Fresh Frozen Plasma (Other)
结局指标
主要结局
Effect of plasmapheresis replacement fluid type on fibrinogen level
时间窗: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type
次要结局
- Effect on coagulation tests after plasmapheresis - ROTEM EXTEM(Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)])
- Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM(Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)])
研究者
Matej Zrimsek
Principal Investigator
University Medical Centre Ljubljana