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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007073
Receipt No. R000003708
Scientific Title Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.
Date of disclosure of the study information 2012/01/16
Last modified on 2015/07/16

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Basic information
Public title Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.
Acronym Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.
Scientific Title Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.
Scientific Title:Acronym Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigate the preventive effect of
VTE and safety of Fondaparinux which is administered 1.5mg/day or 2.5mg/day for 4-8 days (or till discharge from the hospital) after abdominal surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Major bleeding event rate
Key secondary outcomes Frequency of symptomatic PTE or symptomatic DVT

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Start injection of Fondaparinux from 24 +/- 2 hours after surgery and continue administration for 4-8 days.
Interventions/Control_2
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who had Colon cancer surgery and have additional risk factor in Japanese Guideline for Prevention of Venous Thromboembolism
2. Patients who can give informed consent
Key exclusion criteria Criteria related to contraindication and warnings and precautions of anticoagulant (Fondaparinux, Heparin, LMWH, danapanoid)
1. Patients with Bleeding
2. Patients with thrombocytopenia (platelet count less than 100,000 /uL)
3. Patients with complications which may cause bleeding (exclude the target disease of surgery) such as gastrointestinal ulceration, gastrointestinal diverticulitis, colitis, acute bacterial endocarditis, uncontrolled severe hypertension, uncontrolled diabetes, DIC.
4. Patients with severe Hepatic impairment (Child-pugh Category C )
5. Patients with a history of hypersensitivity to heparine, LMWH, danaparoid.
6. Patients with a history of intracerebral hemorrhage.
7. Patients who received brain, spine and eye surgery within 3 months before registration.
8. Patients with severer bleeding than ordinal perioperative bleeding or with difficulty to hemostasis.
9. Severe renal impairment (CCr: less than 20ml / min)

-Other exclude criteria
1. Patients who received major orthopedic surgery (lower limbs), abdominal surgery and cardiovascular surgery within 3 months before the study registration.
2. Patients who received prohibited concomitant drug as follows; Heparin, LMWH, danaparoid, antithrombotic drug, oral anticoagulant (warfalin) , thrombolytic drug, dextran, anti platelet drug (aspirin, clopidogrel, ticlopidine)
3. Patients who diagnosed as VTE at preoperative test
4. Patients whose preoperative D-dimer values are more than 1ug/ml, or 2 times of standard value in the hospital
5. Patients with a history of arterial thromboembolism.
6. Patients with drug addiction or alcoholism
7. Patients who are scheduled other surgery in the study period
8. pregnancy or possibility of pregnant
9. Patients who were tried insertion more than 2 times when catheterization
Patients who are regarded ineligible by doctors with any other reasons
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsugu Sekimoto
Organization Graduate School of Medicine, Osaka University
Division name Department of Surgery, Gastroenterological Surgery
Zip code
Address E2-2-2, Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Email msekimoto@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Ikeda
Organization Graduate School of Medicine, Osaka University
Division name Department of Surgery, Gastroenterological Surgery
Zip code
Address E2-2-2, Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email mikeda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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 大阪大学大学院 医学系研究科 消化器外科学(大阪府)
愛染橋病院(大阪府)
市立芦屋病院(兵庫県)
市立池田病院(大阪府)
市立泉佐野病院(大阪府)
医誠会病院(大阪府)
市立伊丹病院(兵庫県)
町立内海病院(香川県)
NTT西日本大阪病院(大阪府)
国立病院機構 大阪医療センター(大阪府)
大阪警察病院(大阪府)
大阪厚生年金病院(大阪府)
大阪船員保険病院(大阪府)
大阪中央病院(大阪府)
大阪府立急性期・総合医療センター(大阪府)
大阪府立成人病センター(大阪府)
大阪労災病院(大阪府)
大手前病院(大阪府)
市立貝塚病院(大阪府)
加納総合病院(大阪府)
ガラシア病院(大阪府)
川崎病院(兵庫県)
河内総合病院(大阪府)
市立川西病院(兵庫県)
関西労災病院(兵庫県)
社会保険紀南病院(和歌山県)
医誠会病院(大阪府)
近畿大学医学部奈良病院(奈良県)
近畿中央病院(兵庫県)
国立病院機構呉医療センター(広島県)
神戸掖済会病院(兵庫県)
大阪府済生会千里病院(大阪府)
市立堺病院(大阪府)
桜橋渡辺病院(大阪府)
四天王寺病院(大阪府)
市立吹田市民病院(大阪府)
清恵会病院(大阪府)
田仲北野田病院(大阪府)
多根総合病院(大阪府)
市立豊中病院(大阪府)
富田林病院(大阪府)
那智勝浦町立温泉病院(和歌山県)
兵庫県立西宮病院(兵庫県)
西宮市立中央病院(兵庫県)
日生病院(大阪府)
阪和第一泉北病院(大阪府)
阪南中央病院(大阪府)
東大阪市立総合病院(大阪府)
東宝塚さとう病院(兵庫県)
藤本病院(大阪府)
ベルランド総合病院(大阪府)
緑ヶ丘病院(大阪府)
箕面市立病院(大阪府)
守口敬任会病院(大阪府)
八尾市立病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4194009/
Number of participants that the trial has enrolled
Results
Fondaprinux was safe and effective in patients with colorectal cancer resection for the prevention of VTE.
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
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 31 Day
Date of closure to data entry
2011 Year 12 Month 31 Day
Date trial data considered complete
2011 Year 12 Month 31 Day
Date analysis concluded
2012 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 16 Day
Last modified on
2015 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003708

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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