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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003350
Receipt No. R000004067
Scientific Title Examination of utility of prevention and screening tests for pulmonary embolism and deep venus trombosis after total joint replacementof inferior limb.
Date of disclosure of the study information 2010/04/01
Last modified on 2010/03/17

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Basic information
Public title Examination of utility of prevention and screening tests for pulmonary embolism and deep venus trombosis after total joint replacementof inferior limb.
Acronym Prevention and screening tests after totaj joint replacement.
Scientific Title Examination of utility of prevention and screening tests for pulmonary embolism and deep venus trombosis after total joint replacementof inferior limb.
Scientific Title:Acronym Prevention and screening tests after totaj joint replacement.
Region
Japan

Condition
Condition All patients who do total hip replacement and total knee replacement.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We hold anticoagulant therapy to postoperative patients who had THA or TKA, and cofirm this thrombotic protective effects.
In addition, we screen thrombotic presence by blood examination, and review the utility.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Utility of screening tests(FDP D-dimer,Solible fibrine monomer complex)
,thrombotic protective effects of anticoagulation.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Maneuver
Interventions/Control_1 We hold anticoagulant therapy with hypodermic injection of heparin in post operative all cases.heparin is chosen among three kinds at randam(Caprocin, arixtra, CLEXANE).Injections continues for two weeks.
Interventions/Control_2 We do vein of lower extremity echo check on preoperative, post operative 7th, 14th.
Interventions/Control_3 We measures FDP D-dimer by blood examination on postoperative 1st, 3rd, 5th, 7th, 10th and 14th.
In addition, we measures SFMC in preoperative, postoperative 24 hours, 7th day and 14th day.
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

Not applicable
Gender Male and Female
Key inclusion criteria The all cases which do THA or TKA in this hospital.
Key exclusion criteria The patients who has the basal disease that anticoagulation cannot do.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kodaira
Organization Shinshu university school of medicine
Division name Department of orthopaedic surgery
Zip code
Address 3-1-1 Asahi Matumoto-shi Nagano 390-8621 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization shinshu university school
Division name Department of orthopaedic surgery
Zip code
Address
TEL 0263-37-2659
Homepage URL
Email

Sponsor
Institute Department of prthopaedic surgery Shinshu university school of medicine
Institute
Department

Funding Source
Organization Department of prthopaedic surgery Shinshu university school of medicine
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 04 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 Enrolling by invitation
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 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
2010 Year 03 Month 17 Day
Last modified on
2010 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004067

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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