UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015804 |
|---|---|
| Receipt number | R000018390 |
| Scientific Title | Deep venous thrombosis after total knee joint arthroplasty in hemophilia |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2016/06/01 10:02:43 |
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Basic information
Public title
Deep venous thrombosis after total knee joint arthroplasty in hemophilia
Acronym
DVT after TKA in haemophilia
Scientific Title
Deep venous thrombosis after total knee joint arthroplasty in hemophilia
Scientific Title:Acronym
DVT after TKA in haemophilia
Region
| Japan |
Condition
Condition
haemophilia
Classification by specialty
| Orthopedics | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of deep venous thrombosis risk after total knee arthroplasty in coagulation deisease such as haemophilia
Basic objectives2
Others
Basic objectives -Others
relationship with goagulation examination and deep venous thrombosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of deep venous thrombisis before and after total knee arthroplasty
Key secondary outcomes
compairment between the coagulation blood examination and the risk of deep venous thrombosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
on tourniquet during operation
Interventions/Control_2
off tourniquet during operation
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
| Not applicable |
Gender
Male
Key inclusion criteria
indication of total knee arthroplasty
Key exclusion criteria
inhibitor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | takedani hidyeuki |
Organization
research hosipital of institute of medical science
Division name
Joint surgery
Zip code
Address
sirokanedai 4-6-1 Minatoku Tokyo
TEL
03-3443-8111
takedani@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | takedani hidyeuki |
Organization
research hosipital of institute of medical science
Division name
Joint surgery
Zip code
Address
sirokanedai 4-6-1 Minatoku Tokyo
TEL
03-3443-8111
Homepage URL
takedani@ims.u-tokyo.ac.jp
Sponsor or person
Institute
takedani hidyeuki
Institute
Department
Personal name
Funding Source
Organization
research hosipital of institute of medical science
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
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
| 2014 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018390
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
