UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009901 |
|---|---|
| Receipt number | R000010691 |
| Scientific Title | A Multicenter, Open-label, Prospective Randomized Controlled Trial to evaluate the Effect of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Surgery |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2017/05/16 13:08:14 |
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Basic information
Public title
A Multicenter, Open-label, Prospective Randomized Controlled Trial to evaluate the Effect of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Surgery
Acronym
Effect of LMWH on Prevention of VTE after Laparoscopic Surgery
Scientific Title
A Multicenter, Open-label, Prospective Randomized Controlled Trial to evaluate the Effect of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Surgery
Scientific Title:Acronym
Effect of LMWH on Prevention of VTE after Laparoscopic Surgery
Region
| Japan |
Condition
Condition
Gastric or colorectal cancer patients planned to receive laparoscopic surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the additive effect of combined therapy with physical prophylaxis and Low-Molecular-Weight Heparin against thromboembolism compared to physical prophylaxis alone, after laparoscopic surgery for gastric or colorectal cancer by multicenter, open-label, prospective randomized controlled trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
The rate of incidence of all the venous thromboembolism including deep vein thrombosis and pulmonary thromboembolism
Key secondary outcomes
The rate of incidence of pulmonary thromboembolism
The rate of incidence of deep vein thrombosis
The rate of incidence of major and minor bleeding
The rate of incidence of all the adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
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
For patients allocated to the trial group, a subcutaneous injection of enoxaparin 2000 IU twice daily is administered, in addition to conventional physical prophylaxis. Enoxaparin was started 24-36 hours after surgery and continued until 7th post operative day.
Interventions/Control_2
For patients allocated to the control group, conventional physical prophylaxis such as elastic stocking and / or intermittent pneumatic compression device is provided for a few days
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) A patients with histopathologically diagnosed gastric or colorectal cancer
2) Planned to receive laparoscopic surgery.
3) Planned to receive curative operation.
4) Over 40 years old at registration.
5) ECOG Performance Status Scale: 0-2.
6) Able to provide written informed consent.
Key exclusion criteria
1) History of allergic reaction to heparin and / or heparinoid, or heparin-induced thrombocytopenia
2) Coexistence / past history of acute bacterial endocarditis
3) Moderate to severe renal dysfunction (50mL/min >= CCr)
4) Severe liver dysfunction
5) Body weight under 40 Kg
6) During pregnancy and lactation
7) Administration of anticoagulant and / or antiplatelet agent such as warfarin, aspirin and clopidogrel sulfate before operation.
8) Morbid obesity (30<=BMI)
9) Coexistence / clinical sign of venous thromboembolism, past history of venous thromboembolism within one year till the scheduled date of surgery
10) With indwelling central venous catheter
11) Administration of estrogen / progesteronal agents within four weeks prior to the operation.
12) Neo-adjuvant chemotherapy /radiotherapy within four weeks prior to the operation
13) Abnormal high value of D-dimer (=> 10 microg/mL) within four weeks prior to the operation
14) Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naitoh Takeshi |
Organization
Tohoku University Hospital
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
naitot@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Tanaka |
Organization
Tohoku University Hospital
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
Homepage URL
n-tanaka@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastrointestinal Surgery, Department of Surgery, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
NEXTSURG
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
東北大学病院（宮城県）、東北労災病院（宮城県）、仙台厚生病院（宮城県）、仙台市医療センター 仙台オープン病院（宮城県）、みやぎ県南中核病院（宮城県）、宮城県立がんセンター（宮城県）、帯広第一病院（北海道）、東北厚生年金病院（宮城県）、東北中央病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | 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
| 2013 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 30 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010691
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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