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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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19 November 2018 |
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Main ID: |
ChiCTR1800019578 |
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Date of registration:
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2018-11-18 |
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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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Effects of different tranexamic acid regimen in cyanotic pediatric cardiac surgery
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Scientific title:
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Effects of different tranexamic acid regimen in cyanotic pediatric cardiac surgery |
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Date of first enrolment:
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2018-12-01 |
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Target sample size:
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Conventional treatment group:225;Low dose of tranexamic acid group:225;High dose of tranexamic acid group:225; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=32966 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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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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Yu Zhang
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Address:
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167 Lishi Road North, Xicheng District, Beijing, China
100037
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Telephone:
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+86 18611823121 |
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Email:
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jufeyu@163.com |
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Affiliation:
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Department of Anesthesiology, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College |
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Name:
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Yu Zhang
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Address:
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167 Lishi Road North, Xicheng District, Beijing, China
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Telephone:
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+86 18611823121 |
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Email:
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jufeyu@163.com |
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Affiliation:
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Department of Anesthesiology, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients eligible for randomization were men and women aged 1 month to 12 years undergoing primary, isolated;
2. selective radical surgery for Tetralogy of Fallot;
3. Agreed to participate in the study and signed an informed consent.
Exclusion criteria: Patients excluded from the study were those with previous cardiac surgery, preoperative hemoglobin level of <110 g/L, chronic renal insufficiency, chronic hepatic insufficiency, coagulant function abnormality, recent history of anticoagulant therapy, allergy to tranexamic acid.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tetralogy of Fallot
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Intervention(s)
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Conventional treatment group:Childen did not receive an antifibrinolytic agent during surgery;Low dose of tranexamic acid group:Loading dose: 10mg/kg (infant), 5mg/kg (children); Infusion: 2mg/kg.h; CPB prime dose: 20ug/mL of prime volume;High dose of tranexamic acid group:Loading dose: 30mg/kg (infant), 15mg/kg (children); Infusion: 6mg/kg.h; CPB prime dose: 60ug/mL of prime volume;
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Primary Outcome(s)
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Total postoperative blood loss;
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Secondary Outcome(s)
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The volume and exposure of allogeneic transfusion;The incidence of reoperation for bleeding;the maximum hemoglobin level in the first 48 h postoperatively;
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Source(s) of Monetary Support
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the fundamental research funds for the central universities of Peking Union Medical College (No. 3332018064)
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Ethics review
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Status: Approved
Approval date: 23/10/2018
Contact:
Lihuan Li
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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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