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Effects of different tranexamic acid regimen on blood protection in neonates undergoing cardiac surgery: a randomized trial.

Effects of different tranexamic acid regimen on blood protection in neonates undergoing cardiac surgery: a randomized trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069193
Enrollment
Unknown
Registered
2023-03-09
Start date
2023-03-13
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

congenital heart disease

Interventions

Placebo group:receive identical syringes labeled with the randomization number contained saline solution
Low dose of tranexamic acid group:loading dose 15 mg/kg
maintenance dose 5 mg/kg.h
High dose of tranexamic acid group:loading dose 30 mg/kg
maintenance dose 10 mg/kg.h

Sponsors

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 0 day to 31 days ; 2. undergoing primary cardiac surgery with cardiopulmonary bypass; 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 <90 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;

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.com18611823121

Outcome results

None listed

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