Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060802) titled 'Prospective Study of Hemodynamic Changes During Autologous Blood Donation' on March 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Nihon University

Condition: Condition - Patients undergoing autologous blood donation prior to orthognathic surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This prospective study aims to evaluate hemodynamic changes during autologous blood donation (400 mL), which will be utilized as a controlled physiological model of acute hemorrhage.

Measurements will be obtained at three predefined time points: before donation, immediately after donation, and after fluid replacement. No modification of routine clinical management will be made for research purposes.

Hemodynamic parameters including estimated continuous cardiac output (esCCO), estimated stroke volume (esSV), perfusion index (PI), heart rate, and blood pressure will be recorded using non-invasive monitoring. In addition, continuous non-invasive arterial pressure and arterial waveform recordings will be obtained using a finger cuff device.

Small-volume blood samples will be collected through the existing donation line without additional venipuncture to measure hemoglobin and hematocrit levels. The association between hemodynamic parameters and hematologic changes will be analyzed.

This study seeks to clarify physiological circulatory responses to acute blood loss and to evaluate the clinical utility of non-invasive hemodynamic monitoring. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Autologous blood donation (400 mL), performed as part of routine clinical care, will be utilized as a controlled model of acute blood loss. The following additional assessments will be conducted for research purposes:

Non-invasive hemodynamic measurements (esCCO, esSV, PI, blood pressure, heart rate) at three time points: before donation, immediately after donation, and after fluid replacement

Continuous non-invasive arterial pressure and arterial waveform recording using a finger cuff device

Small-volume blood sampling through the existing donation line to measure hemoglobin and hematocrit levels

No modification of therapeutic management will be made for research purposes.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients aged 18 to 65 years

Scheduled for orthognathic surgery under general anesthesia

Planned preoperative autologous blood donation (up to 800 mL)

ASA physical status 1 to 2

Written informed consent obtained Key exclusion criteria - Severe cardiovascular disease (arrhythmia, heart failure, ischemic heart disease)

Anemia (Hb < 11.0 g/dL)

Coagulation disorders or ongoing anticoagulant therapy

Severe hepatic or renal dysfunction

Regular use of medications affecting autonomic nervous function

Pregnancy or breastfeeding

Any condition deemed inappropriate by the investigator Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 02 Day Date of IRB - 2025 Year 06 Month 17 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069562

Disclaimer: Curated by HT Syndication.