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ENROLLING BY INVITATION
NCT07617428

Clinical Validation of a Blood Loss Monitoring System

Sponsor: Lanzhou University Second Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-09-10

Completion Date

2026-06-30

Last Updated

2026-06-23

Healthy Volunteers

No

Locations (3)

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Lanzhou University Frist Hospital

Lanzhou, Gansu, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China