UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013826 |
|---|---|
| Receipt number | R000016137 |
| Scientific Title | Predictors of hypofibrinogenemia in blunt trauma patients on admission |
| Date of disclosure of the study information | 2014/04/29 |
| Last modified on | 2014/11/14 07:31:18 |
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Basic information
Public title
Predictors of hypofibrinogenemia in blunt trauma patients on admission
Acronym
Predictors of hypofibrinogenemia in blunt trauma patients
Scientific Title
Predictors of hypofibrinogenemia in blunt trauma patients on admission
Scientific Title:Acronym
Predictors of hypofibrinogenemia in blunt trauma patients
Region
| Japan |
Condition
Condition
Blunt trauma
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
predictors of hypofibrinogenemia have remained poorly understood. We investigate whether findings available on admission can be used as predictors of hypofibrinogenemia.
Basic objectives2
Others
Basic objectives -Others
investigation for predictors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fibrinogen levels on admission
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
all blunt trauma patients who were tested for serum fibrinogen levels on arrival and were admitted to the hospital.
Key exclusion criteria
Exclusion criteria were arrival at the ED more than 3 h after injury, new injury severity score (NISS) <4 (because most of such patients had insufficient and inadequate records for evaluation), transfer from another hospital, and cardiopulmonary arrest on arrival.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kimura |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
S1W16 Chuou-ku, Sapporo
TEL
0116112111
chiro1123@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kimura |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
S1W16 Chuou-ku, Sapporo
TEL
0116112111
Homepage URL
chiro1123@gmail.com
Sponsor or person
Institute
Yoshinobu Kimura
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
retrospective study
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2014 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016137
