UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060802 |
|---|---|
| Receipt number | R000069562 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 17:09:59 |
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Basic information
Public title
Prospective Study of Hemodynamic Changes During Autologous Blood Donation
Acronym
Hemo-ABD Study
Scientific Title
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
Scientific Title:Acronym
Hemo-ABD Study
Region
| Japan |
Condition
Condition
Patients undergoing autologous blood donation prior to orthognathic surgery
Classification by specialty
| Anesthesiology | Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
This study is an exploratory observational study designed to analyze physiological changes in hemodynamic and hematologic parameters using autologous blood donation as a controlled model of acute hemorrhage. It is not intended to evaluate treatment efficacy or safety.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Change in estimated continuous cardiac output (esCCO) before donation, immediately after donation, and after fluid replacement during autologous blood donation (400 mL)
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kaneko |
Organization
Nihon University School of Dentistry
Division name
Department of Anesthesiology
Zip code
101-8310
Address
1-8-13, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3219-8140
kaneko.keisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kaneko |
Organization
Nihon University School of Dentistry
Division name
Department of Anesthesiology
Zip code
101-8310
Address
1-8-13, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3219-8140
Homepage URL
kaneko.keisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Keisuke Kaneko
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Administration Office, Nihon University School of Dentistry
Address
1-8-13, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
Tel
03-3219-8060
de.institute@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069562
