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IRCT20180909040979N1 IRCT 2019-01-23 Ahvaz University of Medical Sciences The effect of fibrinogen injection on post CABG bleeding The effect of fibrinogen injection on bleeding after Coronary Artery Bypass Graft bleeding 2018-09-23 anticipated 36 Complete https://irct.ir/trial/33958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization: Individuals are randomly divided into two groups based on randomized block randomization method. Randomized blocks are used for this purpose. A random sample based on this method from Sealedenvelope.com has been extracted, Blinding description: Blindness: Patient, surgeon and researcher do not have any information on how to place people in groups. How to Blind: Considering that after dissolving fibrinogen in normal saline, no difference in color compared with normal saline solution, it can be said that the patient, surgeon and researcher do not have any information on how to place them in groups. 3 Presence of aortocoronary bypass graft. Intervention 1: Intervention group: intravenous administration of one gram of fibrinogen dissolved powder manufactured by CSL Behring USA in 100 ml of normal saline after weaning off cardio pulmonary bypass pump. Intervention 2: Control group: intravenous administration of 100 ml of normal saline after weaning off cardio pulmonary bypass pump. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet
public Fatemeh Javaherforoosh zadeh
Imam Khomeini Hospital, Azadegan Ave.
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 0168 f_javaherforoosh@yahoo.com Ahvaz University of Medical Sciences scientific Fatemeh Javaherforoosh zadeh
Imam Khomeini Hospital, Azadegan Ave.
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 0168 f_javaherforoosh@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Elective surgery Coronary artery bypass graft American Society of Anesthesiologist 2-3 50 years 70 years Both Hematologic disorder Liver disease Diabetes (IDDM) Cratinine>130µmol/li Ejection Fraction<%35 Fibrinogen>3.5gr/l Z95.1 Presence of aortocoronary bypass graft Treatment - Drugs Prevention Intervention group: intravenous administration of one gram of fibrinogen dissolved powder manufactured by CSL Behring USA in 100 ml of normal saline after weaning off cardio pulmonary bypass pump Control group: intravenous administration of 100 ml of normal saline after weaning off cardio pulmonary bypass pump Post operative bleeding. Timepoint: 0, 3, 6, 9, 12 and 24 hours after surgery. Method of measurement: blood volume in chest bottels. Hemoglobin. Timepoint: 0, 3, 6, 9, 12 and 24 hours after surgery. Method of measurement: Blood test. Prothrombin time. Timepoint: 0, 6, 12 and 24 hours after surgery. Method of measurement: Blood test. Ahvaz University of Medical Sciences Approved 2018-07-23 The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences., Research Deputy.,Blvd. Golestan Ahvaz Khouzestan Iran (Islamic Republic of)