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Enrolling by invitation NCT07617428

Clinical Validation of a Blood Loss Monitoring System

— Observational Intraoperative Blood Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intraoperative Blood Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective Multicenter Clinical Validation of a Novel Multifunctional Intraoperative Blood Loss Monitoring System

Overview

This observational study aims to evaluate the practicality of a novel multifunctional intraoperative blood loss monitoring system in real-world surgical settings. The primary questions it seeks to address are: Using the direct measurement method as the reference standard, what is the magnitude of measurement error of the monitoring system, and does it tend to overestimate or underestimate blood loss? Does the monitoring system demonstrate superior accuracy compared with visual estimation, the gravimetric method, and the hemoglobin concentration-based method? During surgery, intraoperative blood loss will be measured simultaneously using five approaches: the novel multifunctional monitoring system, the direct measurement method, visual estimation, the gravimetric method, and the hemoglobin concentration method. These measurements will be conducted without interfering with the surgical procedure.

Primary outcome measures

  • Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method [Time frame: At the end of surgery]
Secondary outcome measures (7)
  • Percentage error of the automatic intraoperative blood loss monitor compared with the direct measurement method [Time frame: At the end of surgery]
  • Absolute error of visual estimation compared with the direct measurement method [Time frame: At the end of surgery]
  • Absolute error of the gravimetric method compared with the direct measurement method [Time frame: At the end of surgery]
  • Absolute error of the hemoglobin concentration-based method compared with the direct measurement method [Time frame: 24 hours after surgery]
  • Intraclass correlation coefficient between the automatic intraoperative blood loss monitor and the direct measurement method [Time frame: At the end of surgery]
  • Bland-Altman mean bias between the automatic intraoperative blood loss monitor and the direct measurement method [Time frame: Unit of Measure: Milliliters]
  • Bland-Altman limits of agreement between the automatic intraoperative blood loss monitor and the direct measurement method [Time frame: At the end of surgery]

Eligibility criteria

Inclusion criteria

  • Patients undergoing elective urological or general surgical procedures
  • Age 18 years or older
  • Preoperative hemoglobin concentration available
  • Intraoperative blood loss assessment required during surgery

Exclusion criteria

  • Patients with incomplete intraoperative blood loss measurement data,
  • Severe hemolysis or other conditions that may affect hemoglobin measurement
  • Emergency surgery
  • Intraoperative blood loss assessment required during surgery 24 hours after surgery
  • Refusal to participate, when applicable

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 3 centers
  • Gansu Provincial People's Hospital — Lanzhou
  • Lanzhou University Frist Hospital — Lanzhou
  • Lanzhou University Second Hospital — Lanzhou

Identifiers

NCT: NCT07617428 · 2025A-987

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗