UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the change in autonomic nerve activity and risk factor during circulating blood volume change using autologous blood donation
Acronym	Evaluation of the change in autonomic nerve activity and risk factor during circulating blood volume change
Scientific Title	Evaluation of the change in autonomic nerve activity and risk factor during circulating blood volume change using autologous blood donation
Scientific Title:Acronym	Evaluation of the change in autonomic nerve activity and risk factor during circulating blood volume change
Region	Japan

Condition
Condition	Preoperative patients who undergo autologous blood donation
Classification by specialty	Surgery in general Blood transfusion Intensive care medicine Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of heart rate variability as a marker of autonomic nerve activity, and risk factor during circulating blood volume change
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Autonomic nerve activity (Heart rate variability)
Key secondary outcomes	Blood pressure Heart rate Respiratory rate Laboratory data(Total cholesterol, LDL cholesterol, HDL cholesterol, Triglyceride, HbA1C, Hemoglobin, Hematocrit, Leukocyte, C-reactive protein, Cortisol, etc) Incidence of Vaso-vagal reaction State-Trait Anxiety Inventory-Form JYZ

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Witten informed consent Age>=20 years The patients who undergo elective operation to require transfusion Hb>=11.0g/dL
Key exclusion criteria	Withdrawal of the agreement Frequent arrhythmia Bacterial infection Unstable angina Moderate or severe aortic stenosis(the pressure gradient between left ventricle to the aorta is more than 50mmHg, or the status to need surgery) NYHA:IV Fever(a rise in body temperature above 1 degree from normal, or more than 37.2 degrees)
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Shunsuke Middle name Last name Kawamoto
Organization	Tohoku Medical and Pharmaceutical University
Division name	Faculty of Medicine
Zip code	983-8536
Address	1-15-1 Fukumuro, Miyagino-ku, Sendai, Japan, 983-8536
TEL	022-290-8970
Email	kawamoto@tohoku-mpu.ac.jp

Public contact
Name of contact person	1st name Miho Middle name Last name Kamakura
Organization	Tohoku Medical and Pharmaceutical University
Division name	Faculty of Medicine
Zip code	983-8536
Address	1-15-1 Fukumuro, Miyagino-ku, Sendai, Japan, 983-8536
TEL	022-290-8970
Homepage URL
Email	miho_kamakura_16@yahoo.co.jp

Sponsor
Institute	Tohoku Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Tohoku University Graduate School of Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
Tel	022-717-8007
Email	med-kenkyo@bureau.tohoku.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	東北大学病院(宮城県) / Tohoku University Hospital (Miyagi pref.) 東北医科薬科大学病院(宮城県) / Tohoku Medical and Pharmaceutical University Hospital　(Miyagi pref.)

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 20 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	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 20 Day
Date of IRB	2014 Year 09 Month 22 Day
Anticipated trial start date	2014 Year 10 Month 21 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To analyse autonomic nerve activity and hemodynamics during auotologous blood donation

Management information
Registered date	2014 Year 10 Month 20 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017877