NCT07875114

Brief Summary

This study aims to use artificial intelligence to predict intraoperative bleeding and blood loss in advance for oncologic surgeries with high bleeding risk. The goal is to more accurately determine the type and amount of blood products reserved for patients, improving the efficient use of blood bank resources.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Aug 2025Dec 2026

Study Start

First participant enrolled

August 9, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

1.3 years

First QC Date

September 25, 2026

Last Update Submit

October 13, 2026

Conditions

Keywords

Machine learningPerioperative blood transfusionOncologic surgeryBlood product predictionPatient blood management

Outcome Measures

Primary Outcomes (1)

  • Prediction of Packed Red Blood Cell (PRBC) Transfusion Requirement Using Artificial Intelligence

    In patients undergoing oncologic surgery, the classification performance of an artificial intelligence algorithm-developed using preoperative clinical and laboratory data-in predicting the need for packed red blood cell (PRBC) transfusion (yes/no) will be evaluated against the patient's actual receipt of PRBC transfusion during the perioperative period (from the start of surgery to 24 hours postoperatively). The area under the receiver operating characteristic curve (AUC-ROC) will serve as the primary metric, with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) as supportive metrics.

    Perioperative (from the start of surgery to 24 hours postoperatively)

Secondary Outcomes (3)

  • Prediction of Fresh Frozen Plasma (FFP) Transfusion Requirement Using Artificial Intelligence

    Perioperative (from the start of surgery to 24 hours postoperatively)

  • Comparison of Artificial Intelligence Prediction with Current Clinical Blood Reservation Practice

    Perioperative (from the start of surgery to 24 hours postoperatively)

  • 30-Day In-Hospital Mortality

    30 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged over 18 years with ASA physical status I-III who underwent oncologic surgery at a single center between April 3, 2023, and the date of ethics committee approval, identified retrospectively from hospital medical records.

You may qualify if:

  • Patients over 18 years of age
  • Underwent oncologic surgery
  • ASA physical status I-III

You may not qualify if:

  • Underwent emergency surgery
  • Hematologic disease
  • Pregnancy
  • Incomplete data
  • Underwent cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 15, 2026

Study Start

August 9, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations