UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031264 |
|---|---|
| Receipt number | 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 01:06:51 |
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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
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
t-matsuoka@rgmc.izumisano.osaka.jp
Sponsor or person
Institute
Rinku General Medical Center, Senshu Trauma and Critical Care Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034600
