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SurgeryNCT05228548

Machine Learning Model for Perioperative Transfusion Prediction

An observational study of Surgery and Blood Transfusion, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

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

This study aimed to develop and interpret a machine learning model to predict red blood cell (RBC) transfusion. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Surgery, Blood Transfusion
What is being tested?
Perioperative blood transfusion
How many people
6,121 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Jan 2022to 1 Feb 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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing major elective surgical procedures were considered eligible. All age groups and both genders were included. The surgical procedures were predefined according to the Classification of Diagnostic, Therapeutic, and Surgical Procedures of the National Social Insurance Institution, in which every procedure has a unique cod

Who may be able to join

  • Adult
  • Underwent major elective surgery

Who cannot join

  • Pediatric patients
  • Emergency cases

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dilek D Unal

    Ankara, 06110

Other trials in Turkey (Türkiye)

About this study

Official title: Development and Interpretation of a Machine Learning Model for Perioperative Transfusion Prediction

This study aimed to develop and interpret a machine learning model to predict red blood cell (RBC) transfusion.

Read the detailed description

A dataset from a multicenter study involving 6121 patients underwent elective major surgery was analysed. Data concerning patients who received inappropriate RBC transfusion were excluded. Twenty one perioperative features were used to predict RBC transfusion. The data set was randomly split into train and validation sets (70-30). Decision tree, random forest, k-nearest neighbors, logistic regression, and eXtreme garadient boosting (XGBoost) methods were used for prediction. The area under the curves (AUC) of the receiver operating characteristics curves for the machine learning models used for RBC transfusion prediction were compared.

Being tested
Perioperative blood transfusion
Keywords
Decision tree, eXtreme garadient boosting, k-nearest neighbors, Logistic regression, Machine learning, Prediction model, Random forest, Red blood cell transfusion, Surgery

What participants receive

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

  • Perioperative blood transfusionOther

    Perioperative blood transfusion

What is being measured

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

  1. Number of patients received Red blood cell transfusion

    Number of patients received Red blood cell transfusion

    Measured: Perioperative period

  2. The area under the curve

    The the area under the curve of the receiver operating characteristics curves

    Measured: Perioperative period

Timeline

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

  1. First posted8 Feb 2022
  2. Study start13 Jan 2022
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 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
Other
Time perspective
Prospective
Enrolment
6,121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05228548
Sponsor's protocol ID
Machine learning DiskapiTRH
Status last verified
Jan 2022
First submitted
13 Jan 2022
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.

    PubMed 17998460
  • Bernard AC, Davenport DL, Chang PK, Vaughan TB, Zwischenberger JB. Intraoperative transfusion of 1 U to 2 U packed red blood cells is associated with increased 30-day mortality, surgical-site infection, pneumonia, and sepsis in general surgery patients. J Am Coll Surg. 2009 May;208(5):931-7, 937.e1-2; discussion 938-9. doi: 10.1016/j.jamcollsurg.2008.11.019. Epub 2009 Mar 26.

    PubMed 19476865
  • Walczak S, Velanovich V. Prediction of perioperative transfusions using an artificial neural network. PLoS One. 2020 Feb 24;15(2):e0229450. doi: 10.1371/journal.pone.0229450. eCollection 2020.

    PubMed 32092108

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Blood Transfusion, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

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 2 inclusion and 2 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 8 Mar 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 Turkey (Türkiye). 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?

Number of patients received Red blood cell transfusion (time frame: Perioperative period). The study lists 2 primary outcomes in all. 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 NCT05228548, which also lists 3 linked publications.

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 8 Mar 2022.

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