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Effects of different tranexamic acid regimen in cyanotic pediatric cardiac surgery

Effects of different tranexamic acid regimen in cyanotic pediatric cardiac surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019578
Enrollment
Unknown
Registered
2018-11-18
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot

Interventions

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

Sponsors

National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Total postoperative blood loss;

Secondary

MeasureTime frame
The volume and exposure of allogeneic transfusion;The incidence of reoperation for bleeding;the maximum hemoglobin level in the first 48 h postoperatively;

Countries

China

Contacts

Public ContactYu Zhang

Department of Anesthesiology, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

jufeyu@163.com+86 18611823121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026