UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008273 |
|---|---|
| Receipt number | R000009751 |
| Scientific Title | Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery |
| Date of disclosure of the study information | 2012/07/31 |
| Last modified on | 2018/01/09 19:23:46 |
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Basic information
Public title
Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Acronym
Enoxaparin sodium in gynecological laparoscopy
Scientific Title
Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Scientific Title:Acronym
Enoxaparin sodium in gynecological laparoscopy
Region
| Japan |
Condition
Condition
benign gynecological disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effectiveness and safety of enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
development of VTE after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of enoxaparin sodium
Interventions/Control_2
control (without enoxaparin sodium)
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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
women undergoing laparoscopic surgery for benign gynecological disease
Key exclusion criteria
allergy to heparin or related products
bleeding symptom
acute bacterial endocarditis
history of heparin related thrombocytopenia
renal failure
bodyweight less than 40kg
any clinical signs of VTE at screening or within 1 year before surgery
systemic chemo-therapy within 3 weeks before surgery
radiation therapy within 15 days before surgery
spinal or epidural anesthesia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Masuzaki |
Organization
Nagasaki University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7363
m-kita@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Kitjaima |
Organization
Nagasaki University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7363
Homepage URL
m-kita@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
| 2012 | Year | 07 | 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
| 2012 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009751
