Clinical evident and laboratory investigations of efficacy of three doses of tranexamic acid to avoid fibrinolysis in pediatric cardiac surgery.

• Register: ANZCTR
• Last refreshed on: 16 January 2017
• Main ID: ACTRN12617000045314
• Date of registration: 10/01/2017
• Prospective Registration: Yes
• Primary sponsor: king faisal specialized hospital and research centre
• Public title: Clinical evident and laboratory investigations of efficacy of three doses of tranexamic acid to avoid fibrinolysis in pediatric cardiac surgery.
• Scientific title: Selection of appropriate tranexamic acid dose to prevent fibrinolysis in pediatric cardiac surgery
• Target sample size: 90
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000045314.aspx
• Study type: Interventional
• Study design: Non-randomised trial

Health Condition(s) or Problem(s) studied

pediatric cardiac surgery for congenital heart disease

Intervention(s)

Patients will be divided into three groups according to age: group(A) 0-2 months ,group (B) 2 to 12 months, group(c) more than 12 months but less than 20 kg. Each group will be divided into three groups according to the tranexamic acid dose.
Group (A) will be divided into three subgroups:
A1( low dose group): loading dose given as intravenous bolus 15 mg/kg with induction of anesthesia before skin incision. Intravenous infusion dose given 2.5 mg/kg/hr will be started after the loading dose and stopped by end of skin closure. priming fluid 20ug/ml tranexamic acid added to the priming fluid.
A2 ( Intermediate dose group): intravenous loading dose 50 mg/kg given with induction of anesthesia. Intravenous infusion dose: 7 mg/kg/hr started after loading dose and given through the whole procedure will be stopped by the end of skin closure. priming fluid 60ug/ml.
A3 ( high dose group): intravenous loading dose: 100 mg/kg with induction of anesthesia before skin incision. Intravenous infusion dose will be given with anesthesia induction before skin incision 10 mg/kg/hr given through the procedure and stopped by end of skin closure. priming fluid 100ug/ ml
Group (B) will be divided in three groups:
B1 ( low dose group): intravenous loading dose 9 mg/kg given with induction of anesthesia before skin incision . Intravenous infusion dose: 2 mg/kg/hr given through the procedure and will be stopped by end of skin closure. priming fluid 20 ug/ml.
B2 ( intermediate dose): intravenous loading dose 26 mg/kg given with induction of anesthesia before skin incision. Intravenous infusion dose 6 mg/kg/hr given through the procedure and to be stopped by end of skin closure. priming fluid 60 ug/ml.
B3 (high dose): intravenous loading dose 65mg/kg given with induction of anesthesia before skin incision . Intravenous infusion dose 14 mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 150ug/ml.
Group c will be divided in three subgroups
C1 ( low dose): intravenous loading dose 4 mg/kg given with induction of anesthesia before skin incision . Intravenous infusion dose 2mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 20ug/ml
C2 ( Intermediate dose): intravenous loading dose 13 mg/kg given with induction of anesthesia before skin incision. intravenous infusion dose: 5.5 mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 60ug/ml.
C3 ( high dose): intravenous loading dose: 31 mg/kg given with induction of anesthesia before skin incision. Intravenous Infusion dose: 14 mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 100 ug/ml.
Designated control laboratory tests are thromboelestometry machine and D-dimer will be measured 3 times:
First sample just after induction of anesthesia and after tranexamic loading dose.
Second measurement 15 minutes after start of cardiopulmonary bypass with ongoing tranexamic acid infusion dose.
Third measurement 5 minute after protamine full dose given post bypass.