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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046563
Receipt No. R000052999
Scientific Title Evaluation of preservation environments of preoperative acute normovolemic hemodilution
Date of disclosure of the study information 2022/01/06
Last modified on 2022/01/06

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Basic information
Public title Evaluation of preservation environments of preoperative acute normovolemic hemodilution
Acronym Evaluation of preservation environments of acute normovolemic hemodilution
Scientific Title Evaluation of preservation environments of preoperative acute normovolemic hemodilution
Scientific Title:Acronym Evaluation of preservation environments of acute normovolemic hemodilution
Region
Japan

Condition
Condition Healthy Volunteer
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of preservaion method of preoperative acute normovolemic hemodilution
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in coagulation function(Fibrinogen,PT(%),PT(sec),PT-INR,APTT and Antithrombin3,D-dimer) and platelet count of acute normovolemic hemodilution at 4degree or room temperature (22 degree)
Key secondary outcomes Changes in coagulation factor(Hb,Ht,arterial blood gas analysis and ACT) of acute normovolemic hemodilution at 4degree or room temperature (22 degree)

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 Prevention
Type of intervention
Other
Interventions/Control_1 2 packs of 100ml acute normovolemic hemodilution are removed and divided into the group preservating at 4 degrees and at 22 degree.
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

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria:
healthy volunteer not required reexamination of regular health checkup
Key exclusion criteria exclusion criteria:
bodyweight of 40 kg or less,pregnant women, people donated 200ml whole blood donation,and failure to removed 200ml acute normovolemic hemodilution
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Erika
Middle name
Last name Kataoka
Organization Kochi Medical School Hospital
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 783-8505
Address Kohasu, Okou-cho, Nankoku City, Japan
TEL 088-880-2471
Email jm-erikakataoka@kochi-u.ac.jp

Public contact
Name of contact person
1st name Erika
Middle name
Last name Kataoka
Organization Kochi Medical School Hospital
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 783-8505
Address Kohasu, Okou-cho, Nankoku City, Japan
TEL 088-880-2471
Homepage URL
Email jm-erikakataoka@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School Hospital
Institute
Department

Funding Source
Organization Kochi Medical School Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kochi Medical School Hospital
Address Kohasu, Okou-cho, Nankoku City, Japan
Tel 088-880-2471
Email jm-erikakataoka@kochi-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
2022 Year 01 Month 06 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
2021 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 04 Day
Last follow-up date
2023 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
2022 Year 01 Month 06 Day
Last modified on
2022 Year 01 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052999

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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