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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015481
Receipt No. R000017877
Scientific Title Evaluation of the change in autonomic nerve activity and risk factor during circulating blood volume change using autologous blood donation
Date of disclosure of the study information 2014/10/20
Last modified on 2021/06/22

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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
2022 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
2021 Year 06 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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