UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux.
Title of the study (Brief title)	Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux.
Region	Japan

Condition
Condition	knee replacement surgery
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of factors could explain the adverse effects of individual differences in the treatment of fondaparinux and enoxaparin anticoagulant,further to examine the usefulness of coagulation markers for the diagnosis of thrombos.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	effectiveness and relevance of pharmacokinetics and safety.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Fondaparinux
Interventions/Control_2	Enoxaparin
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	Not applicable
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing knee replacement surgery
Key exclusion criteria	under twenty years. with a history of DVT and PTE. With the disease have abnormal clotting. Patient's written consent not obtained. contraindications to enoxaparin or fondaparinux. The patient has been administered warfarin. Patients with other treating physician deems inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	Yasunori Tsukimura
Organization	Kitasato university, Kitasato institute hospital
Division name	orthopedics
Address	5-9-1 shirokane minato-ku tokyo japan
TEL	03-3444-6161
Email	tsukky@insti.kitasato-u.ac.jp

Public contact
Name of contact person	shibata soichi
Organization	Pharmacy
Division name	Pharmacy
Address	5-9-1 shirokane minato-ku tokyo japan
TEL	03-3444-6161
Homepage URL
Email	shibasoh@insti.kitasato-u.ac.jp

Sponsor
Institute	Kitasato university, Kitasato institute hospital,department of orthopedics
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 08 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 25 Day
Anticipated trial start date	2011 Year 08 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

Management information
Registered date	2011 Year 08 Month 28 Day
Last modified on	2018 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007336