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).
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.
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.
- Conditions
- Surgery, Blood Transfusion
- 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.
Number of patients received Red blood cell transfusion
Number of patients received Red blood cell transfusion
Measured: Perioperative period
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.
- First posted8 Feb 2022
- Study start13 Jan 2022
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 6,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Dokuz Eylul University, Saglik Bilimleri Universitesi, Bulent Ecevit University, Erzincan University, Kahramanmaras Sutcu Imam University, Ufuk University, Istanbul Medeniyet University, Marmara University, Eskisehir Osmangazi University, Inonu University, Mersin University, Istanbul University, Selcuk University, Balikesir University, Trakya University, Necmettin Erbakan University, Ankara University, Suleyman Demirel University, Tobb University of Economics and Technology, Akdeniz University, Uludag University, Ordu University, Gazi University, TC Erciyes University, Hitit University, Firat University, Karadeniz Technical University, Ondokuz Mayıs University, Yuzuncu Yil University, Namik Kemal University, Baskent University, Manisa Celal Bayar University, Osmaniye Government Hospital
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek D Unal, Prof, Principal investigator, UNIVERSITY OF HEALTH SCIENCES TURKEY DISKAPI YILDIRIM BEYAZIT TRAINING RESEARCH HOSPITAL ANKARA
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 17998460Bernard 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 19476865Walczak 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Interpretation of a Machine Learning Model for Perioperative Transfusion Prediction
- ClinicalTrials.gov ID
- NCT05228548
- Acronym / sponsor ID
- Machine learning DiskapiTRH
- Conditions
- Surgery, Blood Transfusion
- Keywords
- Decision tree, eXtreme garadient boosting, k-nearest neighbors, Logistic regression, Machine learning, Prediction model, Random forest, Red blood cell transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,121 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Collaborators
- Hacettepe University, Dokuz Eylul University, Saglik Bilimleri Universitesi, Bulent Ecevit University, Erzincan University, Kahramanmaras Sutcu Imam University, Ufuk University, Istanbul Medeniyet University, Marmara University, Eskisehir Osmangazi University, Inonu University, Mersin University, Istanbul University, Selcuk University, Balikesir University, Trakya University, Necmettin Erbakan University, Ankara University, Suleyman Demirel University, Tobb University of Economics and Technology, Akdeniz University, Uludag University, Ordu University, Gazi University, TC Erciyes University, Hitit University, Firat University, Karadeniz Technical University, Ondokuz Mayıs University, Yuzuncu Yil University, Namik Kemal University, Baskent University, Manisa Celal Bayar University, Osmaniye Government Hospital
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 8 Feb 2022 (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.
This study aimed to develop and interpret a machine learning model to predict red blood cell (RBC) transfusion.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Adult
- Underwent major elective surgery
Key exclusion criteria (2 listed)
- Pediatric patients
- Emergency cases
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 |
|---|---|---|
| Perioperative blood transfusionPerioperative blood transfusion | Other | – |
Primary outcome
Number of patients received Red blood cell transfusion
Time frame: Perioperative period
Number of patients received Red blood cell transfusion
The area under the curve
Time frame: Perioperative period
The the area under the curve of the receiver operating characteristics curves
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 8 Mar 2022.
- Results publication: PubMed 17998460Murphy 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.
- Results publication: PubMed 19476865Bernard 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.
- Results publication: PubMed 32092108Walczak 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.
- 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.
Dilek D Unal, Prof principal investigator
UNIVERSITY OF HEALTH SCIENCES TURKEY DISKAPI YILDIRIM BEYAZIT TRAINING RESEARCH HOSPITAL ANKARA
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 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.