UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033017 |
|---|---|
| Receipt number | R000037638 |
| Scientific Title | Time-dependent coagulation changes in acute normovolemic hemodilutional blood |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2021/06/29 11:20:09 |
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Basic information
Public title
Time-dependent coagulation changes in acute normovolemic hemodilutional blood
Acronym
Coagulation status of acute normovolemic hemodilutional blood
Scientific Title
Time-dependent coagulation changes in acute normovolemic hemodilutional blood
Scientific Title:Acronym
Coagulation status of acute normovolemic hemodilutional blood
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Surgery in general | Obstetrics and Gynecology |
| Oto-rhino-laryngology | Orthopedics | Cardiovascular surgery |
| Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine how long the acute normovolemic hemodilutional blood maintains the coagulation status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A10 and maximum clot firmness (MCF) of INTEM, EXTEM and FIBTEM (ROTEM deltaTM) of autologous blood
Key secondary outcomes
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
Patients who receive acute normovolemic hemodilution under general anesthesia
Key exclusion criteria
Patients who refuse to join the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Saito |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
0358563
Address
zaifu-cho 5, Hirosaki, Aomori, Japan
TEL
0172-39-5113
saitoj@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Saito |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
0368563
Address
zaifu-cho 5, Hirosaki, Aomori, Japan
TEL
0172-39-5113
Homepage URL
saitoj@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine, department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine, department of Anesthesiology
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
institutional review board, Hirosaki University Graduate School of Medicine
Address
zaifu-cho5, Hirosaki
Tel
0172335113
saitoj@hirosaki-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
| 2018 | Year | 07 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we evaluate the coagulation status of the autologous blood. we measure twice using with ROTEM deltaTM just after withdrawing the blood and just before retransfusion to the patients.
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037638
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
