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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031264
Receipt No. R000034600
Scientific Title Impact of initial coagulation and fibrinolytic markers on mortality in severe blunt trauma patients:A multicenter retrospective observational study.
Date of disclosure of the study information 2018/02/14
Last modified on 2020/08/04

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Basic information
Public title Impact of initial coagulation and fibrinolytic markers on mortality in severe blunt trauma patients:A multicenter retrospective observational study.
Acronym Impact of initial coagulation and fibrinolytic markers on mortality in severe blunt trauma patients.
Scientific Title Impact of initial coagulation and fibrinolytic markers on mortality in severe blunt trauma patients:A multicenter retrospective observational study.
Scientific Title:Acronym Impact of initial coagulation and fibrinolytic markers on mortality in severe blunt trauma patients.
Region
Japan

Condition
Condition Trauma
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impacts of initial coagulation and fibrinolytic markers on mortality in patients with severe blunt trauma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 28-day mortality
Key secondary outcomes 24-hour mortality, massive transfusion, cause of death

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 blunt trauma with injury severity score more than or equal to 16
Key exclusion criteria cardiopulmonary arrest on arrival, transferred from other hospitals, pregnant women, patients whose coagulation or fibrinolytic markers were not examined at emergency department
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Kenta
Middle name
Last name Ishii
Organization Rinku General Medical Center
Division name Senshu Trauma and Critical Care Center
Zip code 598-8577
Address 2-23, Rinku Orai-kita, Izumisano, Osaka
TEL 072-469-3111
Email ishiikenta0701@gmail.com

Public contact
Name of contact person
1st name Tetsuya
Middle name
Last name Matsuoka
Organization Rinku General Medical Center
Division name Senshu Trauma and Critical Care Center
Zip code 598-8577
Address 2-23, Rinku Orai-kita, Izumisano, Osaka
TEL 072-469-3111
Homepage URL
Email t-matsuoka@rgmc.izumisano.osaka.jp

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

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka General Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Rinku General Medical Center
Address 2-23, Rinku Orai-kita, Izumisano, Osaka
Tel 072-469-3111
Email web_master@rgmc.izumisano.osaka.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 りんくう総合医療センター(大阪府)、大阪急性期・総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 14 Day

Related information
URL releasing protocol https://sjtrem.biomedcentral.com/articles/10.1186/s13049-019-0606-6
Publication of results Published

Result
URL related to results and publications https://sjtrem.biomedcentral.com/articles/10.1186/s13049-019-0606-6
Number of participants that the trial has enrolled 666
Results
CART analysis revealed that the initial discriminator was fibrinogen (cut-off 130) and the second discriminator was D-dimer (cut-off 110 in the lower fibrinogen subgroup; 118 in the higher fibrinogen subgroup). The 28-day mortality was 90.0% (lower fibrinogen, higher D-dimer), 27.8% (lower fibrinogen, lower D-dimer), 27.7% (higher fibrinogen, higher D-dimer) and 3.4% (higher fibrinogen, lower D-dimer).
Results date posted
2020 Year 08 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 02 Month 28 Day
Baseline Characteristics
The median age was 52 years, and 459 patients were male.
Participant flow
Among the 2666 trauma patients admitted to the two hospitals during the study period, 1069 severe blunt trauma patients were identified. Of these, 403 patients were excluded, and the remaining 666 were included andanalysed.
Adverse events
None
Outcome measures
28-day mortality
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 05 Month 10 Day
Date of IRB
2017 Year 05 Month 17 Day
Anticipated trial start date
2017 Year 06 Month 10 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This was a retrospective observational study conducted from January 2013 to December 2015 at the Rinku General Medical Center and Osaka General Medical Center in Osaka, Japan.

Management information
Registered date
2018 Year 02 Month 13 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034600

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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