UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017294
Receipt No. R000020068
Scientific Title Laboratory monitoring and the anti-coagulant effect of Fondaparinux after total knee arthroplasty
Date of disclosure of the study information 2015/05/15
Last modified on 2015/04/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Laboratory monitoring and the anti-coagulant effect of Fondaparinux after total knee arthroplasty
Acronym Laboratory monitoring and the anti-coagulant effect of Fondaparinux
Scientific Title Laboratory monitoring and the anti-coagulant effect of Fondaparinux after total knee arthroplasty
Scientific Title:Acronym Laboratory monitoring and the anti-coagulant effect of Fondaparinux
Region
Japan

Condition
Condition The patients who will be performed TKA/THA
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-coagulant effect, safety, and the correlation with verious markers of Fondaparinux usage for the patients after TKA/THA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of DVT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Fondaparinux usage (1.5mg) for TKA
Interventions/Control_2 Fondaparinux usage (2.5mg) for TKA
Interventions/Control_3 Fondaparinux usage (1.5mg) for THA
Interventions/Control_4 Fondaparinux usage (2.5mg) for THA
Interventions/Control_5 no usage of Fondaparinux usage for TKA
Interventions/Control_6 no usage of Fondaparinux usage for THA
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who will be performed TKA/THA

more than 20 years old
Key exclusion criteria bleeding risks
bleeding tendency
bleeding history
Operation history within 30 days
Renal failure
Liver failure
History of Hypersensitivity reaction for heparin
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tokifumi Majima
Organization Hokkaido University, Graduate School of Medicine
Division name Department of Joint Replacement and Tissue Engineering
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo
TEL 011-706-5935
Email tkmajima@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Onodera
Organization Hokkaido University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo
TEL 011-706-5935
Homepage URL
Email tomozou@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 27 Day
Last modified on
2015 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.