UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009598
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email jaoki@juntendo.ac.jp

Sponsor
Institute Department of Coloproctological Surgery
Juntendo University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.