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Prospective Study of Hemodynamic Changes During Autologous Blood Donation

Multimodal Assessment of Non-Invasive Hemodynamic Parameters and Hematologic Indices During Autologous Blood Donation as a Controlled Human Model of Acute Hemorrhage: A Prospective Study - Hemo-ABD Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060802
Enrollment
60
Registered
2026-03-02
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing autologous blood donation prior to orthognathic surgery

Interventions

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 r

Sponsors

Nihon University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in estimated continuous cardiac output (esCCO) before donation, immediately after donation, and after fluid replacement during autologous blood donation (400 mL)

Secondary

MeasureTime frame
Changes in estimated stroke volume (esSV), perfusion index (PI), non-invasive arterial pressure and arterial waveform parameters, hemoglobin level, and hematocrit level measured at three time points (before donation, immediately after donation, and after fluid replacement)

Countries

Japan

Contacts

Public ContactKeisuke Kaneko

Nihon University School of Dentistry Department of Anesthesiology

kaneko.keisuke@nihon-u.ac.jp03-3219-8140

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026