UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002444 |
|---|---|
| Receipt number | 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 00:15:40 |
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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
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
Sponsor or person
Institute
unversity of tokushima, surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002991
