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.
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.
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.
- Conditions
- Transfusion-dependent Anemia
- 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 group | Role | What they receive |
|---|---|---|
| Massive Transfusion Positive | Massive Transfusion Positive Receives: Biological: Massive Transfusion of Allogeneic Blood | |
| Massive Transfusion Negative | Massive Transfusion Negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Confusion Matrix Values
Confusion Matrix Values
Measured: 2010-01-01 to 2019-12-31
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.
- First posted23 Apr 2021
- Study start16 Jun 2021
- Primary completion30 Jun 2021
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion-dependent AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-Based Prediction of Major Perioperative Allogeneic Blood Requirements in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04856618
- Acronym / sponsor ID
- PREMATRICS / PREMATRICS
- Conditions
- Transfusion-dependent Anemia
- Keywords
- Artificial Intelligence, Machine Learning, Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,782 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massive Transfusion Positive | – | Biological: Massive Transfusion of Allogeneic BloodMassive Transfusion Positive |
| Massive Transfusion Negative | – | –Massive Transfusion Negative |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As described in the inclusion criteria.
Key inclusion criteria (1 listed)
- All patients that underwent cardiac surgery at the Kepler University Hospital in the period between 2010-01-01 and 2019-12-31.
Key exclusion criteria (3 listed)
- Patients below 18 years of age.
- Presence of congenital heart disease.
- Revision surgery of the same patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massive Transfusion of Allogeneic BloodMassive Transfusion of Allogeneic Blood, > pRBCs | Biological | Massive Transfusion Positive |
Primary outcome
AUROC for Classification of Necessity for Massive Transfusion
Time frame: 2010-01-01 to 2019-12-31
AUROC for Classification of Necessity for Massive Transfusion
2 secondary outcomes
Confusion Matrix Values
Time frame: 2010-01-01 to 2019-12-31
Descriptive Statistics
Time frame: 2010-01-01 to 2019-12-31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 35852544Tschoellitsch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.