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IRCT20180719040524N1 IRCT 2019-07-23 Rajaie Heart Hospital The efficacy of neutralizing heparin by prothamine in cardiac open heart surgery The efficiency and effectiveness of the ACT, ROTEM protocol for neutralizingprotamine heparin in adult patients with open heart surgery (CABG) at ShahidRajaee Cardiovascular Research and Treatment Center 2018-10-23 anticipated 60 Complete https://irct.ir/trial/34431 observational Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Blinding description: Patients undergoing surgery are divided into two intervention and control groups that are divided into the knowledge of the medical staff as well as the patients between the two groups, so that the patients do not know which group they are divided into and after entering the operating room. 2-3 Heart disease. Intervention 1: Our intervention group on the day of operation after taking the anesthetic is taken from the ACT patient at the start of the procedure, and then 3mg / kg heparin is given to prepare the patient for the pump to go. The ACT is acceptable to go to the 420-480sec pump. In order to ensure that this number is taken again, ACT is taken. The pump is also impregnated with 100 milligrams of heparin to prevent the possibility of blood coagulation in the pump ducts. After the patient goes to the pump half an hour later, we take another ACT. And then, depending on the duration of the action, if the discretion and necessity of every hour, an ACT is taken from the patient. At the end of the operation, when you want Let's warm the patient and bring her body temperature to 36.5 degrees from the ROTEM patient as well as the ACT before the pump is turned off. When the patient is transferred to the ICU (ACT), ACT is taken and one hour later if We look at the bleeding from the ROTEM patient in order to investigate the underlying cause. According to this protocol, we try to achieve the optimal dose of heparin and protamine and the dose of the two for the patient from the amount of unwanted bleeding at the end of the patient. Practicing and wasteful use of industrial products. Intervention 2: Control group: Our control group is selected on the basis of anesthesiologists' and epidemiologist's discretion and placed on the routine of the operating room under anesthesia and attached to the pump. Yes - There is a plan to make this available What will be shared: Part of the extracted data from patient analyzes after unidentifiable patients for sharing is possible. When: The publication time of the documentation is considered 3 months after the publication of the results To whom: Access to data is only possible for researchers and professors working in health centers. Conditions: Only a review request for use in future investigations will be allowed. Where to obtain: 1-email: aliasghaffari@gmail.com 2-Mobile: 09126718543; Ali Ghaffari How to obtain: Upon request, the applicant receives documentation about 3 months from the date of receipt of the documentation Comments:
public Seyed Mostafa Alavi
Shahid Rajaie Heart Hospital ;Hashemi Rafsanjani Hwy
Tehran Iran (Islamic Republic of) 1115119969 +98 21 23921 aliasghaffari@gmail.com Islamic Azad University scientific Seyed Mostafa Alavi
Rajaie Heart Hospital;Hashemi Rafsanjani Hwy
Tehran Iran (Islamic Republic of) 1115119969 +98 21 23921 aliasghaffari@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients who do not have an anticoagulant drug Patients undergoing surgery for the first time no limit no limit Both Patients with a history of heart surgery Patients with coagulation disorders Patients with liver and kidney failure I70 Atherosclerosis Treatment - Surgery Treatment - Surgery Our intervention group on the day of operation after taking the anesthetic is taken from the ACT patient at the start of the procedure, and then 3mg / kg heparin is given to prepare the patient for the pump to go. The ACT is acceptable to go to the 420-480sec pump. In order to ensure that this number is taken again, ACT is taken. The pump is also impregnated with 100 milligrams of heparin to prevent the possibility of blood coagulation in the pump ducts. After the patient goes to the pump half an hour later, we take another ACT. And then, depending on the duration of the action, if the discretion and necessity of every hour, an ACT is taken from the patient. At the end of the operation, when you want Let's warm the patient and bring her body temperature to 36.5 degrees from the ROTEM patient as well as the ACT before the pump is turned off. When the patient is transferred to the ICU (ACT), ACT is taken and one hour later if We look at the bleeding from the ROTEM patient in order to investigate the underlying cause. According to this protocol, we try to achieve the optimal dose of heparin and protamine and the dose of the two for the patient from the amount of unwanted bleeding at the end of the patient. Practicing and wasteful use of industrial products. Control group: Our control group is selected on the basis of anesthesiologists' and epidemiologist's discretion and placed on the routine of the operating room under anesthesia and attached to the pump. To investigate more precisely the blood factors and the results of neutralizing the effects of anticoagulant drugs used during surgery, we use the ROTEM device. Timepoint: At the end of the operation, if necessary, an observer will be used. Method of measurement: By ROTEM. Our primary variable is the patient's activated clotting time (ACT). Timepoint: ACT is taken from the beginning of the surgery every hour and ACT is taken at the end of the operation, after neutralizing the effect of heparin ACT. Method of measurement: Measured by ACT. Rajaie Heart Hospital Approved 2018-11-06 Ethics Committee, Faculty of Pharmacy and Pharmaceutical Sciences, Islamic Azad University of Medica No.24;38 street;shahr ara street tehran Tehran Iran (Islamic Republic of)