跳至主要内容
临床试验/NCT02311985
NCT02311985终止不适用

Point-of-care Versus Standard Coagulation Tests Versus Restrictive Strategy to Guide Transfusion in Chronic Liver Failure Patients Requiring Central Venous Line: Prospective Randomized Trial

Hospital Israelita Albert Einstein2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
57
试验地点
2
主要终点
Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization

研究概览

简要总结

The aim of this study is to compare three different blood transfusion strategies for coagulopathy correction before central venous catheterization in patients with chronic liver failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.

详细描述

Central venous catheterization is a ubiquitous procedure in intensive care units and is mainly used for drug administration, hemodynamic monitoring and hemodialysis. Only in US more than five million catheters are inserted annually. One of the main complications associated to central venous lines are the mechanical ones, i.e. arterial puncture, bleeding and hematoma formation, which varies between 5% and 19%. The use of real-time ultrasonography to accomplish central venous catheterization was associated to a drastic reduction in complication rates, and when performed by trained personnel, some series show complications rates <1%, even in patients with coagulopathy.

Patients presenting with chronic liver failure has a complex coagulation system balance, resulting from reduction in the majority of procoagulant and anticoagulant factors, opposed by preservation of thrombin generation. Thus, these patients are prone to develop hemorrhagic and thrombotic phenomena. The coagulation of cirrhotic patients have been classically evaluated by standard coagulation tests. Nevertheless, these tests present important limitations, as evaluation of plasmatic component only, and do not predict bleeding risk. The thromboelastometry is a point-of-care real-time coagulation system evaluation with the advantage of evaluating the cellular and plasmatic components of the coagulation and present a more comprehensive evaluation of blood coagulation, specially in cirrhotics. This technology is associated with reduced costs in diverse clinical settings.

In clinical practice, approximately 90% of physicians empirically transfuse blood components to cirrhotic patients before invasive procedures. This practice is associated to increased risks related to blood transfusion per se, e.g. blood borne infections, immunologic and non-immunologic adverse reactions, to cite some. Several randomized clinical trials have shown that restrictive blood transfusion strategies are associated to better outcomes, including mortality.

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 (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic liver failure (cirrhosis or chronic graft dysfunction) from any cause and medical indication of central venous line placement

排除标准

  • Acute liver failure or
  • Use of therapeutic doses of oral or parenteral anticoagulants (unfractionated heparin or low molecular weight heparin or oral anticoagulants) or
  • Use of oral or parenteral platelet aggregation inhibitors or
  • Patients with von Willebrand syndrome or
  • Over-the-guidewire central venous catheter changing
  • Patients previously included in this study protocol during the same hospital stay

研究组 & 干预措施

Coagulogram-based protocol

Active Comparator

Arm based on standard coagulation tests protocol to guide blood transfusion before central venous catheterization. The possible components to be used include fresh frozen plasma, platelets (random or aphaeresis) and or cryoprecipitate.

干预措施: Coagulogram-based protocol (Other)

Thromboelastometry-based protocol

Experimental

Arm based on rotational thromboelastometry (ROTEM(R)) protocol to guide blood transfusion before central venous catheterization. The possible components to be used include fresh frozen plasma, platelets (random or aphaeresis) and or cryoprecipitate.

干预措施: Thromboelastometry-based protocol (Other)

Restrictive strategy

Experimental

Arm based on a restrictive protocol strategy based on INR/PT and platelets count. The possible components to be used include fresh frozen plasma and/or platelets (random or aphaeresis).

干预措施: Restrictive strategy (Other)

结局指标

主要结局

Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization

时间窗: Day of randomization

次要结局

  • Incidence of hemorrhagic complications associated to central venous catheterization procedure(Day 1)
  • Incidence of acute immunologic and non-immunologic adverse effects of blood transfusion(Day 1)
  • Length of stay in ICU(Up to 90 days)
  • Costs assessments (laboratory and blood transfusion) between the three strategies(Day 1)
  • Length of stay in hospital(Up to 180 days)
  • Mortality rate(Up to 28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Lima Rocha, MD

Adult Critical Care Medicine Attending Physician

Hospital Israelita Albert Einstein

研究点 (2)

Loading locations...

相似试验