UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between venous thrombosis onset and changes in D-dimer levels and Wells score in blunt trauma patients: A prospective observational study
Title of the study (Brief title)	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	Akiyoshi Hagiwara
Organization	National center for global health and medicine
Division name	Department of Emergency Medicine and Critical Care
Address	1-21-1 toyama Shinjuku-ku Tokyo
TEL	03-3202-7181
Email	ahagiwar@hosp.ncgm.go.jp

Public contact
Name of contact person	Hiromitsu Hiruma
Organization	National center for global health and medicine
Division name	Department of Emergency Medicine and Critical Care
Address	1-21-1 toyama Shinjuku-ku Tokyo
TEL	03-3202-7181
Homepage URL
Email	ohmu_ohma@yahoo.co.jp

Sponsor
Institute	National center for global health and medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027091