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IRCT20231021059798N1 IRCT 2023-11-19 Mashhad University of Medical Sciences Assessment the Effect of Positive End-Expiratory Pressure (PEEP) of 15 CmH2O on the Amount of Bleeding After Emergency Coronary Artery Bypass Surgery (CABG) without Using Cardiopulmonary Bypass Pump Assessment the Effect of Positive End-Expiratory Pressure (PEEP) of 15 CmH2O on the Amount of Bleeding After Emergency Coronary Artery Bypass Surgery (CABG) without Using Cardiopulmonary Bypass Pump. 2022-09-23 anticipated 100 Complete https://irct.ir/trial/73374 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocking (blocks of four)- In order to ensure an equal number of patients in the intervention and control groups, 2 patients are assigned to the intervention and 2 patients to the control in each block. Allocation of patients to intervention group and control group in each block is completely random. For example, the sequence of AABB- ABBA- BABA and... can be created in each block according to randomization, Blinding description: Due to obtaining informed consent from the patients before entering the study, the patients do not know how to be assigned to the intervention or control group. Also, the data analyst does not know the group assigned to the patients. N/A Coronary artery occlusion. Intervention 1: Intervention group: after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 15 cm H2O until ventilators is needed. Intervention 2: Control group: after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 5 cm H2O until ventilators is needed. 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 There is no further information
public Ahmad Reza Sadeghipour Kermani
No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City
Mashhad Iran (Islamic Republic of) 9176856587 +98 51 3844 8417 ahmadreza.sadeghipour22@gmail.com Mashhad University of Medical Sciences scientific Ahmad Reza Sadeghipour Kermani
No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City
Mashhad Iran (Islamic Republic of) 9176856587 +98 51 3844 8417 ahmadreza.sadeghipour22@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients who referred to the cardiac emergency department of Imam Reza Hospital with coronary artery occlusion and after performing the initial diagnostic procedures, are candidates for emergency Coronary artery bypass surgery (CABG). All patients who referred to the cardiac emergency department of Qaim Hospital with coronary artery occlusion and after performing the initial diagnostic procedures, are candidates for emergency Coronary artery bypass surgery (CABG). no limit no limit Both Patient's death lack of consent to participate in the study I21.9 Acute myocardial infarction, unspecified Treatment - Other Treatment - Other Intervention group: after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 15 cm H2O until ventilators is needed. Control group: after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 5 cm H2O until ventilators is needed. The amount of bleeding after CABG. Timepoint: In the first 6, 12, and 24 hours after surgery. Method of measurement: The amount of bleeding from pericardial and thoracic drains (in cc). Blood hemoglobin level. Timepoint: In the first 6, 12, 24 and 48 hours after surgery. Method of measurement: Cell Counter. Mashhad University of Medical Sciences Approved 2022-04-26 Ethics committee of Mashhad University of Medical Sciences No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City Mashad Razavi Khorasan Iran (Islamic Republic of)