UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023262 |
|---|---|
| Receipt number | R000026807 |
| Scientific Title | Risk assessment of venous thromboembolism in patient with inflammatory bowel disease |
| Date of disclosure of the study information | 2016/07/21 |
| Last modified on | 2017/02/01 00:25:44 |
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Basic information
Public title
Risk assessment of venous thromboembolism in patient with inflammatory bowel disease
Acronym
Risk assessment of venous thromboembolism in patient with inflammatory bowel disease
Scientific Title
Risk assessment of venous thromboembolism in patient with inflammatory bowel disease
Scientific Title:Acronym
Risk assessment of venous thromboembolism in patient with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the incidence rate and the risk factor of venous thromboembolism in patient with inflammatory bowel disease.
Basic objectives2
Others
Basic objectives -Others
To assess predictive factors of venous thromboembolism in patient with inflammatory bowel disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of venous thromboembolism by computed tomography(CT).
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
Inpatient with inflammatory bowel disease
Key exclusion criteria
(1) Don't having provided voluntary written consent for participation in this study.
(2) Patients judged by investigators ineligible.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Nakagawa |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
tom20852@hospital.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Ohta |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
soccersukisuki4@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
| 2016 | Year | 07 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
Using disorder of blood coagulation as marker,we will assess venous thromboembolism by computed tomography(CT) using a contrast medium.
Management information
Registered date
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2017 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026807
