UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery
Title of the study (Brief title)	Efficacy and safety of Fondaparinux for prevention of venous thromboembolism (VTE) after abdominal surgery
Region	Japan

Condition
Condition	Colorectal cancer patients performed laparoscopic surgery at high risk of VTE
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Asses the incidence of symptomatic/ asymptomatic DVT and symptomatic PTE
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of symptomatic/ asymptomatic DVT and symptomatic PTE
Key secondary outcomes	Incidence of major bleeding

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Colorectal cancer patients performed laparoscopic surgery with VTE risk factor listed Japanese VTE prevention guideline 2. Written informed consent.
Key exclusion criteria	1. Patient who meet contraindication or precaution in package insert of anticoagulants such as Fondaparinux, UFH, LMWH, and Danaparoid 2. Patient who have experience of lower limb orthopedic surgery, abdominal surgery, cardiovascular surgery within 3 month of enrollment 3. Patient who receive contra indicated concomitant drug within 1 week after Fondaparinux administration. 4. VTE patient diagnosed before surgery 5. Patient whose D-dimer above 1 micro gram before surgery 6. Patient who have history of arterial thromboembolism 7. Drug addiction or alcohol abuse. 8. Patient who scheduled other surgery during the study 9. Pregnant women or women who have possibility of pregnancy. 10. Patient who judged inadequate to join the study by the doctor in charge.
Target sample size	100

Research contact person
Name of lead principal investigator	Katsuji Tokuhara
Organization	Kansai Medical University Hirakata hospital
Division name	Department of Surgery
Address	2-3-1, Shinmachi, Hirakata, Osaka 573-1191, Japan
TEL	06-6992-1001
Email	tokuhark@takii.kmu.ac.jp

Public contact
Name of contact person	Katsuji Tokuhara
Organization	Kansai Medical University Hirakata hospital
Division name	Department of Surgery
Address	2-3-1, Shinmachi, Hirakata, Osaka 573-1191, Japan
TEL	072-804-0101
Homepage URL
Email	tokuhark@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 13 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Before this study starts, there are no data.

Management information
Registered date	2011 Year 10 Month 14 Day
Last modified on	2016 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007754