UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043044 |
|---|---|
| Receipt number | R000049113 |
| Scientific Title | Relationship between antithrombin level at the beginning of intensive care unit admission and prognosis |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2022/10/01 09:12:31 |
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Basic information
Public title
Relationship between antithrombin level at the beginning of intensive care unit admission and prognosis
Acronym
Relationship between antithrombin level at the beginning of intensive care unit admission and prognosis
Scientific Title
Relationship between antithrombin level at the beginning of intensive care unit admission and prognosis
Scientific Title:Acronym
Relationship between antithrombin level at the beginning of intensive care unit admission and prognosis
Region
| Japan |
Condition
Condition
All cases admitted to the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If the prediction of severe disease can be shared among medical personnel, it may be possible to provide higher quality medical care. It is less invasive for patients because it can be performed with only one type of blood test. In addition, by combining it with conventional prognosis prediction methods, it may be possible to make more accurate predictions easily.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between AT value at the beginning of intensive care unit admission and death within the hospital stay
Key secondary outcomes
Relationship between AT value at the beginning of intensive care unit admission and 7-day and 28-day mortality after ICU admission; comparison of prognostic value using AT value and APACHE2 score.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients admitted to the Intensive Care Unit (ICU, HCU) of Yamagata University Hospital and the Intensive Care Unit of Nihonkai General Hospital from January 2018 - December 2019 will be included.
Key exclusion criteria
Exclude cases with missing data, cases in which AT or fresh frozen plasma products were used before AT measurement, and very severe cases in which the subject died on the day of admission. Cases in which the subject disagrees with the research use will also be excluded.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kaneyuki |
| Middle name | |
| Last name | Kawamae |
Organization
Yamagata University Medical School Hospital
Division name
Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
023-628-5400
yarimizu.kenya@gmail.com
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Yarimizu |
Organization
Yamagata University Medical School Hospital
Division name
Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
023-628-5400
Homepage URL
yarimizu.kenya@gmail.com
Sponsor or person
Institute
Yamagata University Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamagata University Medical School Hospital department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihonkai General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Medical School Hospital
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel
023-628-5400
yarimizu.kenya@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-312
Org. issuing International ID_1
Yamagata University Medical School Hospital
Study ID_2
30-6-1
Org. issuing International ID_2
Nihonkai General Hospital
IND to MHLW
Institutions
Institutions
山形大学医学部附属病院（山形県）、日本海総合病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | 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
The following information should be collected from the medical record. Patient background. Underlying disease, Blood test results, Treatment, Patient prognosis.
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049113
| 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 |
