UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011667 |
|---|---|
| Receipt number | R000013638 |
| Scientific Title | Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies. |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2018/09/10 19:47:06 |
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Basic information
Public title
Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Acronym
Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Scientific Title
Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Scientific Title:Acronym
Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Region
| Japan |
Condition
Condition
Gastric and colon cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventing efficacy of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of VTE.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Enoxaparin(2000IU twice a day, POD1-7) and mechanical thromboprophylaxis(POD1)
Interventions/Control_2
mechanical thromboprophylaxis(POD1)
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
Postoperative function of the major organs(bone marrow, liver, kidneys, etc.) are held sufficiently; patients that meet the following criteria (hemoglobin : 9.5g/dl or more, ALT and AST: 2.5 times less than the normal value of the facility, total bilirubin: 3.0mg/dl or less, SpO2: 90% or more).
Key exclusion criteria
1)Patients with heparin-induced thrombocytopenia or patients with a history of hypersensitivity of to heparin or related substances(HIT).
2)Patients with acute bacterial endocarditis
3)Patients with severe to moderate renal dysfunction(creatinine clearance below 50mL/min).
4)Patients with severe liver failure.
5)Low-weight patients (weight less than 40kg)
6)Women who may possibly be pregnant or are pregnant.
7)Patients receiving antiplatelet drugs (such as clopidogrel or aspirin) or anticoagulant drugs (warfarin etc.)
affecting hemostasis preoperatively.
8)Patients with venous thromboembolic disease was observed within one year prior to surgery of this study or the patient with clinical signs or merger of deep vein thrombosis.
9)Ppatients with contraindications of
iodinated contrast agent.
10)Patients who have indwelling central venous catheter.
11)Patients treated with progesterone and estrogen formulation within 4 weeks before administration.
12)Patients receiving radiation therapy or systemic cancer chemotherapy within two weeks before the administration.
13)Patients is determined inappropriate as a test target by principal investigator.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido Univ. Graduated School of Medicine
Division name
Gastroenterological Surgery 1
Zip code
Address
N15, W-7, Kita-ku Sapporo, Hokkaido
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kamachi |
Organization
Hokkaido Univ. Graduated School of Medicine
Division name
Gastroenterological Surgery 1
Zip code
Address
N15, W-7, Kita-ku Sapporo, Hokkaido
TEL
011-706-5927
Homepage URL
hkamachi@db3.so-net.ne.jp
Sponsor or person
Institute
Gastroenterological Surgery 1
Hokkaido Univ. Graduated School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gastroenterological Surgery 1
Hokkaido Univ. Graduated School of Medicine
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
| 2013 | Year | 10 | 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
| 2013 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 10 | 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
| 2013 | Year | 09 | Month | 06 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013638
