Blood Component Transfusion Clinical Trial
Official title:
Appropriateness of Frozen Plasma Use in Canada
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.
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.
Generated Research: From the systematic reviews, appropriateness ratings, and the results of
the cohort study, we will have summarized the evidence supporting the use of Frozen Plasma,
produced detailed clinical guidelines outlining the appropriate and inappropriate
indications for Frozen Plasma and provided an understanding of the variation in use and
appropriateness of Frozen Plasma. Each of these elements can then be used by hospitals in
Canada and elsewhere to improve the current use of Frozen Plasma. Understanding of the
variation in Frozen Plasma will allow for a framework to improve transfusion practice and
identify those areas of Frozen Plasma use that merit the greatest attention for further
research.
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Observational Model: Cohort, Time Perspective: Prospective
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|---|---|---|---|
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| Completed |
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