UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026819 |
|---|---|
| Receipt number | 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 | 2020/04/03 09:30:02 |
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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
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
sanki753@gmail.com
Sponsor or person
Institute
Department of Orthopaedic Surgery,
Okayama University Graduate School of Medicine, Dentistry,
and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025875
