UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030582 |
|---|---|
| Receipt number | R000034921 |
| Scientific Title | Effectiveness of low-molecular-weight heparin for prevention of deep venous thrombosis after surgery for colorectal cancer in Japanese patients: a randomized controlled phase III trial |
| Date of disclosure of the study information | 2017/12/26 |
| Last modified on | 2023/12/31 11:46:01 |
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Basic information
Public title
Effectiveness of low-molecular-weight heparin for prevention of deep venous thrombosis after surgery for colorectal cancer in Japanese patients: a randomized controlled phase III trial
Acronym
Effectiveness of low-molecular-weight heparin for prevention of deep venous thrombosis after surgery for colorectal cancer: a randomized controlled phase III trial
Scientific Title
Effectiveness of low-molecular-weight heparin for prevention of deep venous thrombosis after surgery for colorectal cancer in Japanese patients: a randomized controlled phase III trial
Scientific Title:Acronym
Effectiveness of low-molecular-weight heparin for prevention of deep venous thrombosis after surgery for colorectal cancer: a randomized controlled phase III trial
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of low-molecular-weight heparin to prevent deep venous thrombosis after surgery for colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of low-molecular-weight heparin to prevent deep venous thrombosis after surgery for colorectal cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
low-molecular-weight heparin after surgery
Interventions/Control_2
no treatment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients who undergo surgery for colorectal cancer
2) age of 20 or older
3) presence of informed consent
Key exclusion criteria
1) absence of informed consent
2) patients who doctors find unsuited
3) patients with bleeding after surgery
4) patients with preoperative anticoagulant therapy
5) patients with allergy for heparin
6) patients with acute bacteria endocarditis
7) severe renal dysfunction (Ccr<30ml/min)
8) patients with deep venous thrombosis at preoperative ultrasonography
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Metropolitan Hiroo Hospital
Division name
Department of Surgery
Zip code
150-0013
Address
2-34-10 Ebisu, Shibuya-ku, Tokyo
TEL
03-3444-1181
hkoba@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Metropolitan Hiroo Hospital
Division name
Department of Surgery
Zip code
150-0013
Address
2-34-10 Ebisu, Shibuya-ku, Tokyo
TEL
03-3444-1181
Homepage URL
hkoba@med.teikyo-u.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Hiroo Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Hiroo Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Hiroo Hospital
Address
2-34-10 Ebisu, Shibuya-ku, Tokyo
Tel
03-3444-1181
hkoba@med.teikyo-u.ac.jp
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
| 2017 | Year | 12 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034921
