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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-UMIN000026137 |
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Date of registration:
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14/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trial
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Scientific title:
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Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral TKA: randomized controlled trial |
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Date of first enrolment:
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2017/02/15 |
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Target sample size:
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32 |
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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=R000030035 |
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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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Sachiyuki Tsukada |
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Address:
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3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
Japan |
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Telephone:
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0293033003 |
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Email:
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s8058@nms.ac.jp |
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Affiliation:
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Hokusuikai Kinen Hospital Orthopaedic Surgery |
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Name:
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Sachiyuki Tsukada |
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Address:
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3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
Japan |
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Telephone:
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0293033003 |
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Email:
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s8058@nms.ac.jp |
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Affiliation:
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Hokusuikai Kinen Hospital Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Known allergic reaction to tranexamic acid Patients with preoperative hemoglobin level < 11.0 g/dL Refusal of blood products Enrollment in another interventional clinical trial within 6 months prior to surgery
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 knee Rheumatoid arthritis
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Intervention(s)
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The combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first knee. After closure of the capsule and retinaculum, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each knee. Six hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first knee. After closure of the capsule and retinaculum, 10 mL of normal saline was administered intra-articularly for each knee. Six hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
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Primary Outcome(s)
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The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 3
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Source(s) of Monetary Support
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Hokusuikai Kinen Hospital
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Ethics review
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Status: YES
Approval date:
Contact:
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