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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013072
Receipt No. 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 2020/02/09

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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
Email 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
Email information@emergency-medicine.med.thoku.ac.jp

Sponsor
Institute Emergency Center, Tohoku University Hospital
Institute
Department

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
Email 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
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
2020 Year 02 Month 09 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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