UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046563 |
|---|---|
| Receipt number | 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 | 2022/04/10 12:16:58 |
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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, and APTT) of acute normovolemic hemodilution at 4degree or room temperature (22 degree)
Key secondary outcomes
Changes in Hb, Ht, arterial blood gas analysis and platlet (cost/form)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 30ml 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, failure to removed 200ml acute normovolemic hemodilution, and patients with prescribed medicine.
Target sample size
20
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
erikakataoka0627@gmail.com
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
erikakataoka0627@gmail.com
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
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
erikakataoka0627@gmail.com
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
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 | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052999
