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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030630
Receipt No. R000034975
Scientific Title Critical level of plasma fibrinogen during the early phase of severe blunt trauma patients
Date of disclosure of the study information 2017/12/29
Last modified on 2017/12/29

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Basic information
Public title Critical level of plasma fibrinogen during the early phase of severe blunt trauma patients
Acronym Critical level of fibrinogen in severe blunt trauma patients
Scientific Title Critical level of plasma fibrinogen during the early phase of severe blunt trauma patients
Scientific Title:Acronym Critical level of fibrinogen in severe blunt trauma patients
Region
Japan

Condition
Condition trauma
Classification by specialty
Emergency medicine Blood transfusion
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine critical level of plasma fibrinogen in the early resuscitation phase of severe blunt trauma patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In-hospital mortality
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria injury severity score more than or equal to 16
blunt trauma
Key exclusion criteria cardiac arrest on arrival
isolated spinal cord injury without bone fracture
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Idoguchi
Organization Rinku General Medical Center
Division name Senshu Trauma and Critical Care Center
Zip code
Address 2-23, Rinku Orai-kita, Izumisano, Osaka
TEL 072-469-3111
Email idoguchi@ares.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Matsuoka
Organization Rinku General Medical Center
Division name Senshu Trauma and Critical Care Center
Zip code
Address 2-23, Rinku Orai-kita, Izumisano, Osaka
TEL 072-469-3111
Homepage URL
Email t-matsuoka@rgmc.izumisano.osaka.jp

Sponsor
Institute Senshu Trauma and Critical Care Center, Rinku General Medical Center
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2017 Year 12 Month 29 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 Completed
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This was a retrospective cohort study conducted from January 2010 to December 2015 at the Senshu Trauma and Critical Center in Osaka, Japan.

Management information
Registered date
2017 Year 12 Month 29 Day
Last modified on
2017 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034975

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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