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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030582
Receipt No. 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 2018/10/04

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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
Middle name
Last name Hirotoshi Kobayashi
Organization Tokyo Metropolitan Hiroo Hospital
Division name Department of Surgery
Zip code
Address 2-34-10 Ebisu, Shibuya-ku, Tokyo
TEL 03-3444-1181
Email hirotoshi_kobayashi@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotoshi Kobayashi
Organization Tokyo Metropolitan Hiroo Hospital
Division name Department of Surgery
Zip code
Address 2-34-10 Ebisu, Shibuya-ku, Tokyo
TEL 03-3444-1181
Homepage URL
Email hirotoshi_kobayashi@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Hiroo Hospital
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
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
2018 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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