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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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ChiCTR |
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Last refreshed on:
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18 May 2020 |
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Main ID: |
ChiCTR1900025013 |
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Date of registration:
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2019-08-07 |
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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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Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty
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Scientific title:
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Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis |
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Date of first enrolment:
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2019-08-08 |
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Target sample size:
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group 1:52;group 2:52; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=41375 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Kang Bingxin
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Address:
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1474 Yan'an Road West, Changning District, Shanghai
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Telephone:
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+86 18816515076 |
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Email:
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15738314790@163.com |
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Affiliation:
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Shanghai University of Traditional Chinese Medicine |
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Name:
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Xiao Lianbo
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Address:
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540 Xinhua Road, Changning District, Shanghai
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Telephone:
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+86 18621697913 |
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Email:
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xiao_lianbo@163.com |
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Affiliation:
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Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosed as rheumatoid arthritis according to the "Classification of Rheumatoid Arthritis" revised by the American College of Rheumatology in 1978 and the classification of rheumatoid arthritis by the American College of Rheumatology and the European Union of Rheumatology in 2010. Kellgren-LawrenceX line is graded III or IV;
2. Aged 50-75 years;
3. Initial unilateral TKA surgery;
4. Perioperative TXA antifibrinolytic therapy;
5. Preoperative hemoglobin, The coagulation function is normal.
Exclusion criteria: 1. Other types of arthritis (such as primary arthritis, post-traumatic osteoarthritis, gouty osteoarthritis, haemophilic osteoarthritis, and tuberculous arthritis);
2. Bilateral knee arthroplasty (RA patients);
3. Severe cardiovascular disease (such as myocardial infarction, atrial fibrillation, angina pectoris, and cardiac failure) or cerebrovascular disease (such as cerebral infarction and cerebral haemorrhage); and
4. Prolonged use of oral anticoagulant drugs (such as aspirin, warfarin, and clopidogrel).
Age minimum:
50
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Total knee arthroplasty
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Intervention(s)
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group 1:Intravenous infusion of 1g of tranexamic acid at 3 hours after surgery ;group 2:Intravenous infusion of 1g of tranexamic acid at 3, 6, and 12 hours after surgery;
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Primary Outcome(s)
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Hemoglobin;The blood loss;transfusion rate;
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Source(s) of Monetary Support
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The Foundation of Health and Family planning Commission of Shanghai
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Ethics review
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Status: Approved
Approval date: 23/07/2019
Contact:
Zhu Dan
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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