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IRCT20170316033099N11 IRCT 2020-02-19 Birjand University of Medical Sciences Topical and systemic administration of tranexamic acid on pediatric cardiac surgery A clinical trial comparing the effect of topical and systemic administration of tranexamic acid versus its non-administration on bleeding volume and the need for blood products after cardiac surgery in children with congenital heart disease 2019-01-29 anticipated 120 Complete https://irct.ir/trial/45496 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After the patients were enrolled, they were allocated to one of the three study groups using a table of random numbers, Blinding description: The patients and the surgeon were blinded as to which study group the patient was allocated. 3 congenital heart disease. Intervention 1: Intervention group 1 (systemic): After sternotomy, the patient was given 1 milligram per kilogram of tranexamic acid via the cardiopulmonary pump. Subsequently, the patient was prescribed heparin so that the activated clotting time would pass 450 seconds. At the end of the operation, after the patient was discharged from the cardiopulmonary pump, heparin was neutralized upon the administration of protamine sulfate at a dose of one mg per 100 units of heparin. Afterward, one milligram per kilogram of tranexamic acid was re-administered. Intervention 2: Intervention group 2 (topical): After hemostasis and before sternotomy incision was closed, 1 milligram per kilogram bodyweight of tranexamic acid was dissolved in 20 mg of normal saline and poured into the pericardial cavity. Intervention 3: Control group: They received normal saline only. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set When: After the article extracted from the research project is published online or in print and for six months To whom: Readers of the article Conditions: research purposes Where to obtain: Personal correspondence via email to the corresponding author How to obtain: email to the corresponding author Comments:
public Farbod Hatami
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5632 Farbod_2006_123@yahoo.ca Birjand University of Medical Sciences scientific Mahmood Hosseinzadeh Maleki
Imam Reza Hospital, Ibn Sina Ave.
Mashhad Iran (Islamic Republic of) 9137913316 00985131908 HoseinzadehMalekiM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Congenital heart disease Age between one month and 15 years Elective cardiac surgery Surgery performed by one single surgeon Informed consent form signed by the patient's guardian 1 month 15 years Both Treatment with anti-coagulants Presence of hepatic, renal, or respiratory dysfunction Low cardiac output Need for re-surgery Postoperative septicemia Q24.9 Congenital malformation of heart, unspecified Prevention Prevention Placebo Intervention group 1 (systemic): After sternotomy, the patient was given 1 milligram per kilogram of tranexamic acid via the cardiopulmonary pump. Subsequently, the patient was prescribed heparin so that the activated clotting time would pass 450 seconds. At the end of the operation, after the patient was discharged from the cardiopulmonary pump, heparin was neutralized upon the administration of protamine sulfate at a dose of one mg per 100 units of heparin. Afterward, one milligram per kilogram of tranexamic acid was re-administered. Intervention group 2 (topical): After hemostasis and before sternotomy incision was closed, 1 milligram per kilogram bodyweight of tranexamic acid was dissolved in 20 mg of normal saline and poured into the pericardial cavity. Control group: They received normal saline only. Bleeding volume. Timepoint: From the completion of the surgery up to 48 hours after surgery. Method of measurement: Measurement of chest drainage volume in the chest tube. Need for blood products including packed red blood cells, fresh frozen plasma, and platelets. Timepoint: From the completion of the surgery up to 48 hours after surgery. Method of measurement: Measurement of the packs in terms of cc. Birjand University of Medical Sciences Approved 2019-01-28 Ethics Committee of Birjand University of Medical Sciences Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)