Blood Loss, Congenital Heart Disease
Conditions
Keywords
pediatric cardiac surgery, bleeding, tranexamic acid, fibrinolysis, blood loss in pediatric cardiac surgery
Brief summary
Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.
Interventions
DRUGTranexamic Acid
50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.
Sponsors
Okayama University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* children undergoing elective cardiac surgery with cardiopulmonary bypass
Exclusion criteria
* neonate born within 1 month * preoperative inotropes * preoperative mechanical ventilation * preexisting coagulation disorder * reoperation within 48 hours * significant liver or kidney disease * known allergy to TXA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery | 24 hours after surgery |
Secondary
| Measure | Time frame |
|---|---|
| duration of mechanical ventilation | at the time of extubation |
| length of stay in intensive care unit | at the time of discharge from ICU |
| blood loss 6 hours after surgery | 6 hours after surgery |
| re-exploration of chest for excess bleeding | within 24 hours after surgery |
| additional TXA administration | 24 hours after surgery |
| chest closure time (protamine to skin closure) | at the end of surgery |
| episode of thrombotic complication | from drug administration to hospital discharge |
| the amount of blood transfusion | 24 hour after surgery |
Outcome results
None listed