UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009598 |
|---|---|
| Receipt number | R000011258 |
| Scientific Title | Examination of the protective efficacy for vein thromboembolism (VTE) and safety of enoxaparin sodium after the abdominal surgery |
| Date of disclosure of the study information | 2012/12/25 |
| Last modified on | 2012/12/20 22:49:17 |
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Basic information
Public title
Examination of the protective efficacy for vein thromboembolism (VTE) and safety of enoxaparin sodium after the abdominal surgery
Acronym
Examination of enoxaparin sodium after the abdominal surgery
Scientific Title
Examination of the protective efficacy for vein thromboembolism (VTE) and safety of enoxaparin sodium after the abdominal surgery
Scientific Title:Acronym
Examination of enoxaparin sodium after the abdominal surgery
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the protective efficacy of VTE and the risk of bleeding of enoxaparin sodium after the surgery and the bleeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outbreak frequency of symptomatic PTE or VTE judged by imaging study
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Case of surgery targeted for the VTE prevention
Key exclusion criteria
1) The patient who bleeds
2 thrombocytopenia
3) Patient having the complications that may bleed(including a gastrointestinal ulcer, gastrointestinal diverticulitis, colitis, acute bacterial endocarditis, seriously ill high blood pressure, severe diabetes, the DIC).
4) Patient with impaired severe liver function
5) Sensitivity to danaparoid, heparin, low molecular weight heparin.
6) The patient who has the past of cerebral hemorrhage
7) The patient who received the operation of the central nervous system or ophthalmology within three months before registration of the final examination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aoki Jun |
Organization
Juntendo University
Division name
Department of Coloproctological Surgery
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University
Division name
Department of Coloproctological Surgery
Zip code
Address
TEL
Homepage URL
jaoki@juntendo.ac.jp
Sponsor or person
Institute
Department of Coloproctological Surgery
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Coloproctological Surgery
Juntendo University Faculty of Medicine
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
| 2012 | Year | 12 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examination non-enforcement
Management information
Registered date
| 2012 | Year | 12 | Month | 20 | Day |
Last modified on
| 2012 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011258
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| Registered date | File name |
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| Registered date | File name |
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