UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Deep venous thrombosis after total knee joint arthroplasty in hemophilia
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	takedani hidyeuki
Organization	research hosipital of institute of medical science
Division name	Joint surgery
Address	sirokanedai 4-6-1 Minatoku Tokyo
TEL	03-3443-8111
Email	takedani@ims.u-tokyo.ac.jp

Public contact
Name of contact person	takedani hidyeuki
Organization	research hosipital of institute of medical science
Division name	Joint surgery
Address	sirokanedai 4-6-1 Minatoku Tokyo
TEL	03-3443-8111
Homepage URL
Email	takedani@ims.u-tokyo.ac.jp

Sponsor
Institute	takedani hidyeuki
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018390