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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000026819 |
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Date of registration:
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01/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients. |
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Date of first enrolment:
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2016/11/21 |
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Target sample size:
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80 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025875 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Tomonori
Tetsunaga |
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Address:
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2-5-1, Shikata-cho, Kita-ku, Okayama City, Okayama,700-8558, Japan
Japan |
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Telephone:
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086-235-7273 |
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Email:
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tomonori_t31@yahoo.co.jp |
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Affiliation:
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Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Orthopaedic Surgery |
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Name:
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Tomoaki
Sanki |
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Address:
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2-5-1, Shikata-cho, Kita-ku, Okayama City, Okayama,700-8558, Japan
700-8558
Japan |
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Telephone:
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086-235-7273 |
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Email:
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sanki753@gmail.com |
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Affiliation:
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Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip
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Intervention(s)
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Dose: Edoxaban group; Edoxaban 15mg per day Enoxaparin gropu; Enoxaparin 2000 IU per day
Intervention period: for 10 days after the surgery
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Primary Outcome(s)
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VTE incidence on the 6th to 8th postoperative day.
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 15/11/2016
Contact:
mae6605@adm.okayama-u.ac.jp
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
086-235-6503
mae6605@adm.okayama-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/11/2019 |
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URL:
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