- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532772
Transfusion Practices in Intensive Care Units: a Hungarian Nationwide Survey
The aim of our data analysis-based questionnaire study is to assess the daily transfusion practices used in the care of critically ill patients in intensive care units in Hungary.
The rate and frequency of the application of physiological parameters (serum lactate level, central venous oxygen saturation and arteriovenous carbon dioxide difference, arteriovenous oxygen content difference) recommended as transfusion triggers in the international literature in daily practice will be assessed.
The aim of our survey is not only to collect statistical data, but also to map practical experiences, knowledge, opinions and possible institutional differences. Our aim is to obtain a more comprehensive picture of the operation of the care system, including transfusion activities, and any possible different practices applied in individual institutions, based on the experiences and observations of colleagues directly involved in patient care.
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of our study is to assess the transfusion practice applied in the care of anemic, critically ill patients in intensive care units in Hungary.
In this study, we examine the rate and frequency of the application of physiological parameters (serum lactate level, central venous oxygen saturation and arteriovenous carbon dioxide difference, arteriovenous oxygen content difference) recommended as transfusion triggers in the international literature in everyday practice.
This is a non-interventional, cross-sectional observational survey study. We use a descriptive, Hungarian-language online questionnaire (Google Forms, Google Inc., Mountain View, CA) survey regarding the transfusion practice of intensive care units in Hungary is based on 15 mandatory and 1 optional question. Participation in the study is completely voluntary and anonymous. No personal or other sensitive data is recorded or stored during the data collection process, so respondents cannot be identified. The names of the responding institutions are registered solely for the purpose of geographical distribution of responses.
The MedCalc statistical analysis software (MedCalc Software bvba, Ostend, Belgium) was used to evaluate the questionnaires, and the results were expressed as a percentage of the number of respondents, using a 95% confidence interval. The normality of the data was checked using the Kolmogorov-Smirnov test. The data were presented as mean ± standard deviation in the case of normal distribution, and median (interquartile range) in the case of non-normal distribution. The relationship between the different subgroups (specialist trainees vs. specialists; university centers vs. public hospitals) was examined using Pearson's correlation. The analysis between the groups was performed using the chi-square test, and the relationship between the use of the PBM program and transfusion triggers was examined using a two-way repeated measures analysis of variance (2-way RM ANOVA). A p<0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pest County
-
Kistarcsa, Pest County, Hungary, 2143
- Flór Ferenc Hospital Kistarcsa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Hungarian anesthesiologists and intensive care practitioners
Exclusion criteria:
- Anesthesiologists and intensive care practitioners working in non-Hungarian intensive care units
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hungarian intensivists
|
The questionnaire consists of 15 mandatory and 1 optional question.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The practice of applying physiological parameters that trigger the need for blood transfusion as assessed by the survey questionnaire
Time Frame: through study completion (2 months)
|
The primary endpoint of the study is the use of physiological parameters (serum lactate level, central venous oxygen saturation, arteriovenous carbon dioxide difference and arteriovenous oxygen content difference) indicating oxygen deficiency / oxygen debt underlying tissue oxygenation disorders in determining the indication for red blood cell transfusions in critically ill patients treated in the intensive care unit.
|
through study completion (2 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of departmental transfusion practice
Time Frame: through study completion (2 months)
|
Assessment of the application of restrictive versus liberal transfusion policy
|
through study completion (2 months)
|
|
Assessment of the existence and availability of Patient Blood Management (PBM) programs in the respondents' institutions based on the survey questionnaire
Time Frame: through study completion (2 months)
|
Number of institutions where the PBM program is available and its elements are applied in everyday practice will be reported
|
through study completion (2 months)
|
|
Correlation between applying the PBM program guidelines and the use of transfusion triggers as assessed by the survey questionnaire
Time Frame: through study completion (2 months)
|
To examine how the application of the PBM guideline affects respondents' daily practices regarding the use of physiological triggers for blood transfusion.
|
through study completion (2 months)
|
|
Transfusion protocol
Time Frame: through study completion (2 months)
|
Availability of a written transfusion protocol adapted to the intensive care unit
|
through study completion (2 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zoltán Ruszkai, MD, PhD, Flór Ferenc Hospital Kistarcsa
- Study Chair: Csanád Geréd, MD, Flór Ferenc Hospital Kistarcsa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM/8863-3/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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