UMIN-CTR Clinical Trial

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	76
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	Terminated
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	2020 Year 04 Month 03 Day

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