UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015481 |
|---|---|
| Receipt number | 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 | 2022/05/01 21:21:46 |
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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
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
miho_kamakura_16@yahoo.co.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017877
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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