UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008435 |
|---|---|
| Receipt number | R000009923 |
| Scientific Title | Phase III study of efficacy of fondaparinux on the prevention of post-operative venous thromboembolism in patients undergoing with laparoscopic colorectal cancer surgery. |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2016/06/30 15:23:46 |
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Basic information
Public title
Phase III study of efficacy of fondaparinux on the prevention of post-operative venous thromboembolism in patients undergoing with laparoscopic colorectal cancer surgery.
Acronym
Phase III VTE prevention study of fondaparinux in colorectal cancer patients.
Scientific Title
Phase III study of efficacy of fondaparinux on the prevention of post-operative venous thromboembolism in patients undergoing with laparoscopic colorectal cancer surgery.
Scientific Title:Acronym
Phase III VTE prevention study of fondaparinux in colorectal cancer patients.
Region
| Japan |
Condition
Condition
Colorectal cancers
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of fondaparinux (2.5mg/day or 1.5mg/day for 4 to 8 days) in the prevention of venous thromboembolism in patients with colorectal cancer .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of venous thromboembolism (VTE)
Key secondary outcomes
Incidence of major bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Once daily fondaparinux (2.5mg or 1.5mg) for 4 to 8 days after 24 hours of surgery
Interventions/Control_2
Intermittent pneumatic compression according to the institutional guidelines
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 under going laparoscopic colorectal surgery and have additional risk factor for VTE.
2) Patients with confirmed colorectal cancer by endoscopic examination.
3) Patients of age=>70
4) Sufficient function of important organs (obrained within 42 day of registration)
1.WBC: >=3,000 /mm3
2. Platelet : >= 100,000 /mm3
3.Total bil: <= 2.0 mg/dl
4.AST, ALT : <=100 IU/L
6.Serum creatinin : <= 1.5 mg/dL
5) Pre-operative D-dimer < 1ug/ml or less than twice of institution limit
6)With written informed consent
Key exclusion criteria
1) Patients with active bleeding
2)Thrombocytopenia plt<10x104/uL
3) Patients with a risk of bleeding: GI ulcers, diverticulitis, colitis, acute bacterial endocarditis, uncontrolled severe hypertension, Uncontrolled diabetes mellitus, DIC
4) Severe liver dysfunction (Child C)
5) Known hypersensitivity of unfractionated heparin, low molecular heparin, and heparinoids)
6) History of cranial bleeding
7) Patients underwent central cranial operation, spine operation or ophthalmic surgery within 3 months before registration
8) Severe renal dysfunction (Cr clearance < 20ml/min)
9) Known hypersensitivity of contrast media
10) Other patients who are unfit for the study as determined by the attending physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Yasui |
Organization
Kaizuka City Hospital
Division name
Department of Surgery, Gastroenterological Surgery
Zip code
Address
10-20, 3 Chome, Hori, Kaizuka-City, Osaka, 597-0015, Japan
TEL
072-422-5865
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Division name
Department of GI Surgery
Zip code
Address
2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2016 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009923
