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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026819
Receipt No. R000025875
Scientific Title A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients.
Date of disclosure of the study information 2017/04/01
Last modified on 2019/04/05

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Basic information
Public title A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients.
Acronym A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients.
Scientific Title A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients.
Scientific Title:Acronym A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients.
Region
Japan

Condition
Condition osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, in step with the aging of the population, patients with geriatric or renal disfunction who need total hip arthroplasty has been increased. These patients have to have postoperative anticoagulant therapy for prevention of venous thromboembolism safety and effectively. However, there is no RCT for patients with geriatric or low body weight or renal disfunction.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VTE incidence on the 6th to 8th postoperative day.
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Dose:
Edoxaban group; Edoxaban 15mg per day
Enoxaparin gropu; Enoxaparin 2000 IU per day
Interventions/Control_2 Intervention period:
for 10 days after the surgery
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 and Female
Key inclusion criteria 1. elderly; over 75 years old
and/or
2. low weight; 40 kg < BW < 50 kg
and/or
3. Moderate renal function disorder; 30 mL/min < Ccr < 50 mL/min
Key exclusion criteria 1. Ccr < 30 mL/min
2. common use of anticoagulant, antiplatelet and the P glucoprotein repressor
3. perioperative amount of bleeding more than 600 ml
4. allergic to iodine contrast agent
5. Under 20 years old
6. inappropriate as a study subject
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Tetsunaga
Organization Okayama University Graduate School of Medicine, Dentistry,
and Pharmaceutical Sciences
Division name Department of Orthopaedic Surgery
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama City, Okayama,700-8558, Japan
TEL 086-235-7273
Email tomonori_t31@yahoo.co.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Sanki
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Orthopaedic Surgery
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama City, Okayama,700-8558, Japan
TEL 086-235-7273
Homepage URL
Email sanki753@gmail.com

Sponsor
Institute Department of Orthopaedic Surgery,
Okayama University Graduate School of Medicine, Dentistry,
and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, Kita-ku, Okayama City, Okayama,700-8558, Japan
Tel 086-235-6503
Email mae6605@adm.okayama-u.ac.jp

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
2017 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
2016 Year 11 Month 15 Day
Anticipated trial start date
2016 Year 11 Month 21 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 01 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025875

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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