跳至主要内容
临床试验/NCT01187030
NCT01187030已完成不适用

Appropriateness of Frozen Plasma Use in Canada

Ottawa Hospital Research Institute0 个研究点目标入组 2,580 人开始时间: 2008年5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
2,580
主要终点
The primary outcome for the appropriateness of Frozen Plasma transfusions will be the proportion of appropriate transfusion episodes.

研究概览

简要总结

There is little evidence to guide the current use of Frozen Plasma. Despite this, over 260,000 units of frozen plasma are transfused in Canada annually. Based on the limited published data available, the pattern of practice for Frozen Plasma transfusions is highly variable and an important number of Frozen Plasma transfusions appear to be inappropriate. Given inappropriate use, it is inevitable that a percentage of patients experience unnecessary and potentially life-threatening adverse transfusion reactions. Current guidelines for Frozen Plasma offer little help in guiding specific clinical decisions as their recommendations lack sufficient clinical details. This lack of detail also hinders the utility of these guidelines to help monitor and improve clinical practice. Further research examining Frozen Plasma transfusions including an understanding our current use is critical to improve the utilization of this valuable and limited resource.

详细描述

Objectives: We will (1) systematically review the evidence for the use of Frozen Plasma transfusions, (2) establish appropriateness ratings for all clinical scenarios for which Frozen Plasma is transfused, and (3) perform a 3-month prospective study to understand the current use and the appropriateness of use of Frozen Plasma in 12 Canadian academic centres.

Methods and Analysis: Following a well established methodology to evaluate medical therapies developed at RAND/UCLA, the investigators will purposively employ different epidemiologic techniques to assess the current use and appropriateness of Frozen Plasma transfusions in Canada.

First, we will undertake a thorough systematic review of the evidence for the use of Frozen Plasma across all indications.

The RAND modified Delphi methodology will then be used to determine the appropriateness of transfusing Frozen Plasma across a comprehensive set of clinical scenarios. A panel of 9 experts representing relevant clinical specialties will use the evidence from the systematic review to determine the appropriateness ratings (an ordinal scale of 1-9) for each clinical scenario.

Subsequently, we will undertake a prospective cohort study of all episodes of Frozen Plasma transfusions (approximately 5000 episodes) at 10 Canadian academic centres (17 hospitals) using the appropriateness ratings. Trained research assistants will identify all transfusion episodes via the blood bank and perform a chart review to obtain demographic variables (age, sex, weight), clinical variables (diagnosis, coagulopathy, indications for frozen plasma transfusions, other blood product transfusions), and laboratory (pre and posttransfusion coagulation tests) information. These data will allow mapping of each transfusion event onto a specific clinical scenario rated by the expert panel and the assignment of an appropriateness rating. We will also determine the total number of patients and the number of patients for each of the largest user groups of Frozen Plasma at each hospital. The primary outcomes for the prospective cohort study, the proportion of inappropriate transfusions (appropriateness) and the proportion of patients transfused (overall utilization), will be initially examined using descriptive statistics. Using hierarchical modeling, a logistic regression analysis will be used to examine the proportion of inappropriate transfusions while controlling for indication, hospital, and patient factors. For the analysis of overall utilization of Frozen Plasma, a chi-square analysis will be used to compare the proportion of patients transfused in the largest user groups at the different hospitals. A secondary analysis will examine the dose of Frozen Plasma transfused.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • All subjects receiving frozen plasma or PCC transfusions

排除标准

  • No subjects excluded -

结局指标

主要结局

The primary outcome for the appropriateness of Frozen Plasma transfusions will be the proportion of appropriate transfusion episodes.

时间窗: 2 months

Each transfusion episode will be the unit of analysis as a single patient may receive both inappropriate and appropriate transfusions.

次要结局

  • The number of units transfused per patient will be the secondary outcome.(2 months)

研究者

申办方类型
Other
责任方
Sponsor

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