UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020235 |
|---|---|
| Receipt number | R000023369 |
| Scientific Title | Exploratory Clinical Trial for Efficacy and Safety of Short-term (3 days) Enoxaparin on Prevention of Venous Thromboembolism after Gastric Cancer Surgery |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2018/06/20 00:06:19 |
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Basic information
Public title
Exploratory Clinical Trial for Efficacy and Safety of Short-term (3 days) Enoxaparin on Prevention of Venous Thromboembolism after Gastric Cancer Surgery
Acronym
Efficacy and Safety of Short-term (3 days) Enoxaparin on Gastric Cancer Surgery
Scientific Title
Exploratory Clinical Trial for Efficacy and Safety of Short-term (3 days) Enoxaparin on Prevention of Venous Thromboembolism after Gastric Cancer Surgery
Scientific Title:Acronym
Efficacy and Safety of Short-term (3 days) Enoxaparin on Gastric Cancer Surgery
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 3-day use of low molecular weight heparin (enoxaparin) combined with intermittent pneumatic compression on prevention of postoperative venous thromboembolism for gastric cancer patients over 40 years of age who are planned to receive gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of venous thromboembolism at 8 to 14 days after surgery
Key secondary outcomes
Incidence of bleeding-related adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Subcutaneous injection of enoxaparin (2000IU, twice a day, from night of the 1st day to morning of the 4th day, 6 times in total) in combination with intermittent pneumatic compression
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically-diagnosed gastric cancer who are planned to receive total, distal, proximal or partial gastrectomy (surgical approach do not matter)
2) Patients over 40 years of age
3) Patients who can give written informed concent
Key exclusion criteria
1) Patients with past history of venous thromboembolism
2) Patients with past history of allergic reaction to heparin or heparinoid (including low molecular weight heparin)
3) Patients with active bleeding (except for bleeding from gastric cancer planned to be resected by surgery)
4) Patients with acute bacterial endocarditis
5) Patients with severe renal dysfunction (Ccr < 30mL/min)
6) Patients with past history of heparin-induced thrombocytopenia
7) Patients who are otherwise judged by the investigator as unsuitable for enrollment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyoshi Fujiwara |
Organization
Okayama University
Division name
Gastroenterological Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7257
toshi_f@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Kuroda |
Organization
Okayama University
Division name
Gastroenterological Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7257
Homepage URL
shinkuro@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Gastroenterological Surgery, Okayama University
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
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
| 2016 | Year | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2018 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023369
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
