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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009901
Receipt No. 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

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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
Email 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
Email n-tanaka@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of Gastrointestinal Surgery, Department of Surgery, Tohoku University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010691

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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