RecruitingACTRN12617000045314

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

Selection of appropriate tranexamic acid dose to prevent fibrinolysis in pediatric cardiac surgery

Sponsor

king faisal specialized hospital and research centre

Enrollment

90 participants

Start Date

Nov 28, 2016

Study Type

Interventional

Conditions

pediatric cardiac surgery for congenital heart disease

Summary

Tranexamic acid inhibits fibrinolysis and decreases bleeding in surgical patients especially in cardiac surgeries. There is no consensus over its dose. Different centers use different doses during cardiac surgeries. Even in the same hospital different physicians give different doses of tranexamic acid during adult and pediatric cardiac surgeries. Recently, a pharmacokinetic model has been made by Wesley et al that has depicted three different doses to achieve the optimum plasma level. These doses have not been validated clinically or by the laboratory tests to find the optimum dose that inhibits fibrinolysis and decreases bleeding. We would like to find out the optimum dose of tranexamic acid by using the doses of the Wesley’s pharmacokinetics model. We will measure the extent of fibrinolysis done by these doses through clinical observations and laboratory tests.

Eligibility

Sex: Both males and femalesMax Age: 13 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for children undergoing open-heart surgery and looks at the best dose of a medication called tranexamic acid, which helps prevent excessive bleeding during surgery. Different hospitals currently use different doses, and this study tests three specific doses to find out which one best controls bleeding while being safe for young patients. You may be eligible if: - Your child is under 13 years of age - Your child needs cardiac (heart) surgery - Your child falls into one of three age groups: 0–2 months, 2–12 months, or over 12 months You may NOT be eligible if: - Your child has kidney failure - Your child has liver failure - Your child has a blood clotting disorder - Your child is on blood-thinning medications - The surgery is an emergency - Your child has a history of seizures Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

Locations(1)

jeddah, Saudi Arabia

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ACTRN12617000045314