Clinical trial

Prediction of Transfusion-Associated Complications

Name
PRETRACO
Description
Currently, about 350000 red blood cell concentrates are produced from blood donations in Austria every year. In addition to the main effect of replacing lost blood, red blood cell concentrates also have many undesirable effects - from blood group compatibilities, which are easily avoidable due to care, to storage-related side effects, to mostly intensive care problems as a result of massive transfusions, to system-wide effects such as TRALI, TACO and TRIM. Before being administered to patients, red blood cell concentrates undergo an extensive quality assurance process in which a large number of parameters are collected. Prior to use on patients, for example, bedside tests and tests for further incompatibilities with a blood sample from the intended patient are performed. With the implementation of Patient Blood Management (PBM) in recent years, the use of red cell concentrates has become more targeted - the number of transfusions is decreasing in most developed countries. However, it is still possible to suffer transfusion-related adverse events (TRAE). Thus, active research activity to reduce these TRAEs continues to be called for. To date, however, it is not known which patients experience transfusion-related adverse events. Despite the broad measures of hemovigilance and pre-transfusion testing, it is still not possible to predict which individual patient will respond to a transfusion with a typical adverse event such as hypotension, hemolysis, renal failure, or TRALI. It seems understandable that characteristics of the patient as well as characteristics of the administered unit could play a role for this. In particular, it is conceivable that a combination of characteristics of the blood unit and characteristics of the patient could determine a complication in the course of administration. For this reason, it seems attractive to use artificial intelligence and machine learning methods to predict any complications.
Trial arms
Trial start
2022-07-15
Estimated PCD
2022-07-31
Trial end
2022-07-31
Status
Completed
Treatment
Transfusion of Allogeneic Blood
Transfusion of Allogeneic Blood
Arms:
AKI, AKI and ARF, ARF, no complication
Size
3366
Primary endpoint
AUROC for Classification of AKI
2016-10-31 to 2020-08-31
AUROC for Classification of ARF
2016-10-31 to 2020-08-31
AUROC for Classification of AKI and ARF
2016-10-31 to 2020-08-31
Eligibility criteria
Inclusion Criteria: * All adult patients that received at a blood transfusion the Kepler University Hospital in the period between 2016-10-31 to 2020-08-31. Exclusion Criteria: None.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 3366, 'type': 'ACTUAL'}}
Updated at
2023-04-26

1 organization

1 product

1 indication