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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002444
Receipt No. R000002991
Scientific Title Randomized study of anti-coagulant therapy to preventpostoperative deep venous thrombosis/pulmonary embolism
Date of disclosure of the study information 2009/10/01
Last modified on 2009/09/04

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Basic information
Public title Randomized study of anti-coagulant therapy to preventpostoperative deep venous thrombosis/pulmonary embolism
Acronym Randomized study of anti-coagulant therapy to preventpostoperative deep venous thrombosis/pulmonary embolism
Scientific Title Randomized study of anti-coagulant therapy to preventpostoperative deep venous thrombosis/pulmonary embolism
Scientific Title:Acronym Randomized study of anti-coagulant therapy to preventpostoperative deep venous thrombosis/pulmonary embolism
Region
Japan

Condition
Condition Patients after diegstive surgery classified high risk in DVT/PE prevention guide line
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify frequency of VTE and adverse events after treatment of enoxaparin, fondaparinux and heparin sodium
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of VTE
Key secondary outcomes freqauency of adverse events including hemorrhage and abnormal seroligical findings

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 enoxaparin 2000IU 2/day 7days
Interventions/Control_2 fondaparinux 2.5mg 1/day 7says
Interventions/Control_3 heparin sodium 5000IU 2/day 7days
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 1
Key exclusion criteria 1
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shimada mitsuo
Organization university of tokushima
Division name surgery
Zip code
Address kuramotocho 3-18-15, tokusima, japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization university of tokushima
Division name surgery
Zip code
Address
TEL 0886339276
Homepage URL
Email

Sponsor
Institute unversity of tokushima, surgery
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)

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
2009 Year 10 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 Open public recruiting
Date of protocol fixation
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 04 Day
Last modified on
2009 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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