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Safety and Efficacy of Tranexamic Acid in Pediatric Cardiac Surgery: a double-blind randomized controlled trial

Safety and Efficacy of Tranexamic Acid in Pediatric Cardiac Surgery: a double-blind randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024131
Enrollment
Unknown
Registered
2019-06-26
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

Congenital heart disease

Interventions

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. Pediatric patients aged 31 days to 7 years undergo cardiac surgery with cardiopulmonary bypass including surgical repair of atrial or ventricular septal defect, atrioventricular septal defect, endocardial cushion defect or complete repair for tetralogy of Fallot, double outlet right ventricle, transposition of the great arteries, pulmonary atresia, anomalous pulmonary venous connection, anomalous origin of the left coronary artery from pulmonary artery, ect. 2. The patients are willing to participate after reading and signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pediatric patients undergo total cavopulmonary connection with cardiopulmonary bypass. 2. Thrombocytopenia or any other known history of bleeding disorder. 3. Thromboembolic disease: history of postoperative or spontaneous pulmonary embolism, spontaneous arterial thrombosis, or familial hypercoaguability. 4. Previous convulsion or seizure. 5. Patients with intellectual or legal disabilities. 6. Severe renal impairment (serum creatinine>3.3 mg/dL). 7. Allergy or contraindication to TXA injection or its components. 8. Currently enrolled in another perioperative interventional study.

Design outcomes

Primary

MeasureTime frame
postoperative seizure;the volume of allogeneic red blood cell transfusion after termination of cardiopulmonary bypass;

Secondary

MeasureTime frame
stroke;myocardial infarction;pulmonary embolism;deep venous thrombosis;renal dysfunction;death;the volume and exposure of allogeneic blood transfusion after termination of cardiopulmonary bypass;postoperative bleeding;the rate of reoperation;use of extracorporeal membrane oxygenation;

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 20, 2026