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OpenTrials
Completed

NCT Number: NCT05466370

Prediction of Transfusion-Associated Complications

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hospital

Linz, Upper Austria, 4021, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transfusion of Allogeneic Blood

Biological

Transfusion of Allogeneic Blood

Primary outcomes

  1. AUROC for Classification of AKI

    Time frame: 2016-10-31 to 2020-08-31

    AUROC for Classification of AKI

  2. AUROC for Classification of ARF

    Time frame: 2016-10-31 to 2020-08-31

    AUROC for Classification of ARF

  3. AUROC for Classification of AKI and ARF

    Time frame: 2016-10-31 to 2020-08-31

    AUROC for Classification of AKI and ARF

Secondary outcomes

  1. Confusion Matrix

    Time frame: 2016-10-31 to 2020-08-31

    Confusion Matrix Results: true positives, true negatives, false positive, false negatives and values calculated from these results.

  2. Descriptive Statistics

    Time frame: 2016-10-31 to 2020-08-31

    Descriptive Statistics (age in years, gender as male/female, blood group as A, B, 0, AB, hemoglobin in g/dl, platelets in count/microliter, leukocytes in cells per liter, CRP in mg/dl, creatinine in mg/dl, GFR ml/minute, glucose in mg/dl, potassium in mmol/l, TT, aPTT in seconds, ALT U/liter, paO2 mmHg, Rhesus type as positive or negative, height in cm, weight in kg, body temperature in kg, age of blood in days, cholesterine in mg/dl, systolic blood pressure in mmHg, diastolic blood pressure in mmHg)

    This outcome measure will compare the individual feature (e. g. height in cm) in one group vs. the other. Significant difference will be described by p-value.

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Acronym: PRETRACO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2022
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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