UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023625 |
|---|---|
| Receipt number | R000027091 |
| Scientific Title | Relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients: A prospective observational study |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/02/17 19:43:54 |
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Basic information
Public title
Relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients: A prospective observational study
Acronym
Relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients
Scientific Title
Relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients: A prospective observational study
Scientific Title:Acronym
Relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients
Region
| Japan |
Condition
Condition
venous thromboembolism(VTE)
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether it contributes to the improvement of diagnosis of venous thrombosis to check relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients who have to rest on a bed for a long time.
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of VTE
Key secondary outcomes
1. frequency of VTE over 65 years old
2. complication rate of pulmonary embolism
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Blunt trauma patient over 18 years old who came to our hospital by an ambulance and admitted in the emergency department
2. Patients who do not meet exclusion criteria
3. Patients who disagree to take part in the study
Key exclusion criteria
1. Trauma in upper limb only
2. Mild head injury (GCS14-15)
3. Congenital coagulopathy
4. Have taken anticoagulant therapy already
5. Malignant disease end-stage
6. Refusal of aggressive intensive treatment
7. Chronic renal disease
8. Irreversible severe hepatic disease
9. Contrast agent allergy
10. Patient or others disagree to take part in the study
11. Have deep venous thrombosis during first visit
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Hagiwara |
Organization
National center for global health and medicine
Division name
Department of Emergency Medicine and Critical Care
Zip code
Address
1-21-1 toyama Shinjuku-ku Tokyo
TEL
03-3202-7181
ahagiwar@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Hiruma |
Organization
National center for global health and medicine
Division name
Department of Emergency Medicine and Critical Care
Zip code
Address
1-21-1 toyama Shinjuku-ku Tokyo
TEL
03-3202-7181
Homepage URL
ohmu_ohma@yahoo.co.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
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
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
国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027091
