Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 8
- 主要终点
- Procedure-related relevant bleeding, occurring within 24 hours after the procedure.
研究概览
简要总结
With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.
详细描述
Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.
Objective
With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).
Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •18 years and older
- •INR >1.5 and <3.0
- •undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)
排除标准
- •clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses)
- •thrombocytopenia of < 30 x 109/L.
- •use of abciximab, tirofiban, ticlopidine or activated protein C
- •use of heparin < 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses < 12 hours prior to procedure
- •history of congenital or acquired coagulation factor deficiency or bleeding diathesis
- •no informed consent
结局指标
主要结局
Procedure-related relevant bleeding, occurring within 24 hours after the procedure.
时间窗: 24 hours after the procedure
Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill. An assessment of bleeding will be standardized and performed by an independent research physician or intensivist blinded to the transfusion strategy 1 and 24 hours after the procedure and when clinically indicated.
次要结局
- minor bleeding within 24 hours(within 24 hours of the procedure)
- onset of acute lung injury within 48 hours.(48 hours within the intervention)
- effect of FFP transfusion on coagulation parameters(within 24 hours of transfusion of FFP)
- evaluation of costs(up to 28 days after inclusion)