UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006543 |
|---|---|
| Receipt number | R000007754 |
| Scientific Title | Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery |
| Date of disclosure of the study information | 2013/12/31 |
| Last modified on | 2016/10/06 20:40:37 |
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Basic information
Public title
Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery
Acronym
Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery
Scientific Title
Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery
Scientific Title:Acronym
Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery
Region
| Japan |
Condition
Condition
Colorectal cancer patients performed laparoscopic surgery at high risk of VTE
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Asses the incidence of symptomatic/ asymptomatic DVT and symptomatic PTE
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of symptomatic/ asymptomatic DVT and symptomatic PTE
Key secondary outcomes
Incidence of major bleeding
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Colorectal cancer patients performed laparoscopic surgery with VTE risk factor listed Japanese VTE prevention guideline
2. Written informed consent.
Key exclusion criteria
1. Patient who meet contraindication or precaution in package insert of anticoagulants such as Fondaparinux, UFH, LMWH, and Danaparoid
2. Patient who have experience of lower limb orthopedic surgery, abdominal surgery, cardiovascular surgery within 3 month of enrollment
3. Patient who receive contra indicated concomitant drug within 1 week after Fondaparinux administration.
4. VTE patient diagnosed before surgery
5. Patient whose D-dimer above 1 micro gram before surgery
6. Patient who have history of arterial thromboembolism
7. Drug addiction or alcohol abuse.
8. Patient who scheduled other surgery during the study
9. Pregnant women or women who have possibility of pregnancy.
10. Patient who judged inadequate to join the study by the doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuji Tokuhara |
Organization
Kansai Medical University Hirakata hospital
Division name
Department of Surgery
Zip code
Address
2-3-1, Shinmachi, Hirakata, Osaka 573-1191, Japan
TEL
06-6992-1001
tokuhark@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuji Tokuhara |
Organization
Kansai Medical University Hirakata hospital
Division name
Department of Surgery
Zip code
Address
2-3-1, Shinmachi, Hirakata, Osaka 573-1191, Japan
TEL
072-804-0101
Homepage URL
tokuhark@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata hospital
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
| 2013 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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
Before this study starts, there are no data.
Management information
Registered date
| 2011 | Year | 10 | Month | 14 | Day |
Last modified on
| 2016 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007754
