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Transfusion-dependent AnemiaPREMATRICSNCT04856618

Machine Learning-Based Prediction of Major Perioperative Allogeneic Blood Requirements in Cardiac Surgery

An observational study of Transfusion-dependent Anemia, run by Kepler University Hospital at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiac surgery is one of the clinical surgical specialties that carries a particularly high risk for patients to suffer from severe bleeding perioperatively and consequent anemia, which subsequently requires transfusion of allogeneic blood. Read more about this study

Who is it for?
Any age
Conditions the study is for
Transfusion-dependent Anemia
What is being tested?
Massive Transfusion of Allogeneic Blood
How many people
3,782 participants
Where
1 siteAustria
Study dates
16 Jun 2021to 20 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: As described in the inclusion criteria.

Who may be able to join

  • All patients that underwent cardiac surgery at the Kepler University Hospital in the period between 2010-01-01 and 2019-12-31.

Who cannot join

  • Patients below 18 years of age.
  • Presence of congenital heart disease.
  • Revision surgery of the same patient.

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Kepler University Hospital

    Linz, Upper Austria, 4021

Other trials in Austria

About this study

Cardiac surgery is one of the clinical surgical specialties that carries a particularly high risk for patients to suffer from severe bleeding perioperatively and consequent anemia, which subsequently requires transfusion of allogeneic blood.

Although a surprisingly high number of patients in cardiac surgery do not require perioperative transfusions, it is primarily those patients who do require transfusion who are subsequently at risk for a worse outcome.

Read more

In recent years many studies have been published discussing measures that can assist physicians in avoiding the triad of anemia, bleeding, and transfusion in cardiac surgery. Within these publications, the implementation of Patient Blood Management (PBM) is advised. PBM is a set of measures aimed at improving patient outcome by reducing perioperative bleeding and thus preventing both anemia and bleeding.

The three pillars of this bundle are the preoperative preparation of anemic patients with iron, erythropoietin, folic acid and vitamin B12, the prevention of intraoperative blood loss and the reasonable indication for allogeneic transfusions.

Nevertheless, it must be mentioned that the implementation of at least part of these measures is laborious, and full implementation of the recommended bundle is therefore rarely achieved. As a consequence, the full potential of Patient Blood Management is not always realized. Unfortunately this means that transfusion of allogeneic blood cannot be prevented in many patients.

A small proportion of patients undergoing cardiac surgery requires a very large amount of allogeneic blood perioperatively. These patients are typically those with a particularly poor outcome. Massive transfusion of allogeneic blood in this situation is an indicator of complications and a cause of increased mortality.

Although cardiac surgeons and anesthesiologists believe they can assess which patients are at high risk for hemorrhage, recent publications indicate that there is an urgent need for adequate predictive methods. A variety of studies exist that attempt to predict perioperative transfusion requirements, but to date have been plagued by several limitations. Either the previous publications do not focus on the prediction of massive transfusion of allogeneic blood, i.e. administration of ten or more packed red blood cell units perioperatively, but on much lower transfusion volumes, have only low predictive strength to predict massive transfusion in daily clinical practice, or are hardly usable for true prediction because they use factors (features) that are not strictly present only in the preoperative phase.

If an accurate prediction model based on a few features could be created and those patients particularly at risk of massive transfusion of allogeneic blood could be identified, it would subsequently be possible to develop an adapted clinical pathway that would allow patient care to be improved and individualized interventions adapted to the situation to be implemented.

In the best case, an adapted care of patients would be possible, which is able to increase the acceptance for the use of even complex measures of patient blood management. This is especially true for measures such as preoperative preparation with iron and/or erythropoietin, the use of a cell saver, and a particularly careful surgical approach.

Even if it is difficult to apply all measures of patient blood management in all patients, it would be possible with an approach as described to identify those patients who would benefit most from individualized approaches.

Being tested
Massive Transfusion of Allogeneic Blood
Keywords
Artificial Intelligence, Machine Learning, Transfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Massive Transfusion of Allogeneic BloodBiological

    Massive Transfusion of Allogeneic Blood, > pRBCs

Study groups in NCT04856618
Study groupRoleWhat they receive
Massive Transfusion PositiveMassive Transfusion Positive
Receives: Biological: Massive Transfusion of Allogeneic Blood
Massive Transfusion NegativeMassive Transfusion Negative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUROC for Classification of Necessity for Massive Transfusion

    AUROC for Classification of Necessity for Massive Transfusion

    Measured: 2010-01-01 to 2019-12-31

Secondary outcomes (2)
  1. Confusion Matrix Values

    Confusion Matrix Values

    Measured: 2010-01-01 to 2019-12-31

  2. Descriptive Statistics

    Descriptive Statistics (age, gender, EuroSCORE II, ASA, NYHA, CCS, main surgical procedure, ventricular ejection fraction, endocarditis present, myocardial infarction present, chronic pulmonary disease, immediacy requirement of procedure (elective, emergency), arteriopathy present, diabetes present, previous cardiac surgery done, critical condition present, aortic surgery, pulmonary hypertension present, renal impairment (none, moderate, severe, dialysis)).

    Measured: 2010-01-01 to 2019-12-31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start16 Jun 2021
  3. Primary completion30 Jun 2021
  4. Study completion20 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,782 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856618
Sponsor's protocol ID
PREMATRICS
Acronym
PREMATRICS
Status last verified
Nov 2022
First submitted
16 Apr 2021
Last updated
29 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tschoellitsch T, Bock C, Mahecic TT, Hofmann A, Meier J. Machine learning-based prediction of massive perioperative allogeneic blood transfusion in cardiac surgery. Eur J Anaesthesiol. 2022 Sep 1;39(9):766-773. doi: 10.1097/EJA.0000000000001721. Epub 2022 Jul 20.

    PubMed 35852544

Questions about this trial

What is this clinical trial studying?

An observational study of Transfusion-dependent Anemia, run by Kepler University Hospital at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUROC for Classification of Necessity for Massive Transfusion (time frame: 2010-01-01 to 2019-12-31). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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