UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013072 |
|---|---|
| Receipt number | R000015237 |
| Scientific Title | Analysis of hemostasis of aged trauma patients and investigation for noble biomarker related to hemostasis |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2023/02/11 13:55:29 |
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Basic information
Public title
Analysis of hemostasis of aged trauma patients and investigation for noble biomarker related to hemostasis
Acronym
Analysis of hemostasis of aged trauma patients and investigation for noble biomarker related to hemostasis
Scientific Title
Analysis of hemostasis of aged trauma patients and investigation for noble biomarker related to hemostasis
Scientific Title:Acronym
Analysis of hemostasis of aged trauma patients and investigation for noble biomarker related to hemostasis
Region
| Japan |
Condition
Condition
Trauma
Classification by specialty
| Surgery in general | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of hemostasis of aged trauma patients and identfy coagulation factors or alarmins as biomarkers related to hemostasis
Basic objectives2
Others
Basic objectives -Others
Exploration
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate difference of hemostasis function between aged and younger trauma patients, between with patients brain injury or not, between patients with shock or not.
To show the relation of hemostasis function and alarmins level.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Severe trauma patients admitted to Tohoku University Hospital with injury portion of Abbreviated Injury Score (AIS) 3 or more and received one or more of interventions as any transfusion, transarterial embolisation or surgery for hemostasis, or close observation for bleeding portion.
Key exclusion criteria
under 16 years old
Patients or family don`t agree to participate in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Hospital
Division name
Emergency Center
Zip code
9808574
Address
1-1 Seiryo-machi Aoba-ku, Sendai
TEL
+81-22-717-7489
kudodaisuke@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Hospital
Division name
Emergency Center
Zip code
9808574
Address
1-1 Seiryo-machi Aoba-ku, Sendai
TEL
+81-22-717-7489
Homepage URL
information@emergency-medicine.med.thoku.ac.jp
Sponsor or person
Institute
Emergency Center, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology, Japan
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
Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi Aoba-ku, Sendai
Tel
+81-22-717-8007
med-kenkyo@grp.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
5
Results
Main outcome was not analyzed because sufficient number of patients was not collected.
Results date posted
| 2020 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Measurement and data collection
1) Hemostasis function analyzed by ROTEM at admission, 3 hrs and 24 hrs after admission.
1) Patients demographics
2) Vitals signs and laboratory date at admission
3) Treatment and transfusion
4) Coagulation factors, alarmins and cytokines at admission and 24 hrs after admission
Relationship between age and these factors will be analyzed.
Management information
Registered date
| 2014 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015237
| 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 |
