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IRCT20220610055128N1 IRCT 2023-03-02 Esfahan University of Medical Sciences The Evaluation of the impact of reduction in the Protamine dose in comparison to its total dose after coronary artery bypass grafting Evaluation and comparison of bleeding and Activated Clotting Time (ACT) after coronary artery bypass grafting in protamine-heparin injection 1: 1 and protamine-heparin 0.5: 1 2023-03-10 anticipated 60 Complete https://irct.ir/trial/64095 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling in two super specialist hospital Milad and Chamran in Isfahan is done. Patients portion from each one of this two hospitals determined with portion apportionment formula. For defined portion of each hospital to be assigned individuals for each hospital to A group and B group to be used the method double randomized blocks. In this way that with reference to the hospital reception by patients, respectively each two persons that have inclusion criteria, considered as one block and this blocking for each hospital continue until the enough blocks according to sample size. After formation each block, people of each block they are arranged according to the national code, this matter running in total blocks equally and by using random number table, if let the number 0 to 4 first person is allocated to A group and the second person is allocated to B group, if let the number 5 to 9 first person is allocated to B group and second person to A group. Eventually persons are allocated to A group or B group. Nomenclature is placed in envelope and is delivered to reception area in operating room. In operating room determine an evaluator that again specifies that which one to recieve routine treatment and which one recieve new treatment with random number table. If let the number 0 to 4 consider A group routine that is mean to give total dose Protamine Sulfate and if let the number 5 to 9 consider B group routine, and then give other group new treatment that is mean decrease Protamine Sulfate to half dose of routine dose. Without us knowing that which one has received patient routine treatment and which one new treatment. When we go to collect and analyze data this evaluator informs relationship individuals to A or B group and type of treatment, Blinding description: In this study, participants and caretakers including nurses and doctors and implication evaluators are totally unaware of the categorization of participants into which study groups and all the interference procedures are utterly similar as regards the aspects of appearance such as the volume and the color of the drug and the type and the volume of the serum used for infusion and also the time frame needed for the drug to be administered. 3 Patients in need of coronary artery bypass grafting. Intervention 1: Intervention group: This group involve 30 person that intervention means reduction Protamine dose to the half the usual amount in they is done. In this group relative to the amount received Heparin, in the end of surgery, a half dose of Protamine receive in 15 minutes as infusion in 100 milliliter of Normal saline serum. 5 minuets after the end of Protamine receipt, evaluate Activated Clotting Time level with coagulometer device. Bleeding level control after 12 hours and 36 hours after surgery through evaluation blood drainage level inside of the chest tubes box. Heparin as Heparin Sodium, it is produced in SHAHID GHAZI PHARMACEUTICAL company as 5000 unit in milliliter in ampule and Protamine as Protamine Sulfate, it is produced in Ronak pharmaceutical company as 1000 unit in milliliter in 5 milliliter in vial. Intervention 2: Control group: This group involve 30 person that intervention means reduction Protamine dose in they it is not done . In this group relative to the amount received Heparin, in the end of surgery, a one dose of Protamine receive in 15 minutes as infusion in 100 milliliter of Normal saline serum. 5 minuets after the end of Protamine receipt, evaluate Activated Clotting Time level with coagulometer device. Bleeding level control after 12 hours and 36 hours after surgery through evaluation blood drainage level inside of the chest tubes box. Heparin as Heparin Sodium , it is produced in SHAHID GHAZI pharmaceutical company as 5000 unit in milliliter in ampule and Protamine as Protamine3Sulfate, it is produced in Ronak pharmaceutical company as 1000 unit in milliliter in 5 milliliter in vial. 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 I have not yet decide; I may later publish it.
public Dr.Amir MirMohammadSadeghi
Shahid Chamran Heart Hospital, After Shahrestan bridge, 3tMoshtagh,isfahan
Isfahan Iran (Islamic Republic of) 81583-88997 +98 31 3260 0961 am-sadeghi@mui.ac.ir Esfahan University of Medical Sciences scientific Amir Mirmohammadsadeghi
Shahid Chamran Heart Hospital, After Shahrestan bridge, 3tMoshtagh St, Isfahan
Isfahan Iran (Islamic Republic of) 81583-88997 +98 31 3260 0961 am-sadeghi@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Omitting anti-coagulation drugs at least one week prior to surgery Patient should be a candidate for coronary artery bypass grafting Informed consent to participate in the study CPB duration less than 100 minutes 18 years no limit Both Allergy and the risk of anaphylaxia shock Coagulation abnormality Bleeding and hemostasis dysfunctions due to non-medical causes Patients dependent on dialysis and patients suffering from blood dyscrasia and known platelet dysfunction Pregnancy Heparin re-administration Need for emergency surgery Patients with BMIs higher than 30 Under 28 degrees hypothermia Dissent to participate in the study Treatment - Drugs Treatment - Drugs Intervention group: This group involve 30 person that intervention means reduction Protamine dose to the half the usual amount in they is done. In this group relative to the amount received Heparin, in the end of surgery, a half dose of Protamine receive in 15 minutes as infusion in 100 milliliter of Normal saline serum. 5 minuets after the end of Protamine receipt, evaluate Activated Clotting Time level with coagulometer device. Bleeding level control after 12 hours and 36 hours after surgery through evaluation blood drainage level inside of the chest tubes box. Heparin as Heparin Sodium, it is produced in SHAHID GHAZI PHARMACEUTICAL company as 5000 unit in milliliter in ampule and Protamine as Protamine Sulfate, it is produced in Ronak pharmaceutical company as 1000 unit in milliliter in 5 milliliter in vial. Control group: This group involve 30 person that intervention means reduction Protamine dose in they it is not done . In this group relative to the amount received Heparin, in the end of surgery, a one dose of Protamine receive in 15 minutes as infusion in 100 milliliter of Normal saline serum. 5 minuets after the end of Protamine receipt, evaluate Activated Clotting Time level with coagulometer device. Bleeding level control after 12 hours and 36 hours after surgery through evaluation blood drainage level inside of the chest tubes box. Heparin as Heparin Sodium , it is produced in SHAHID GHAZI pharmaceutical company as 5000 unit in milliliter in ampule and Protamine as Protamine3Sulfate, it is produced in Ronak pharmaceutical company as 1000 unit in milliliter in 5 milliliter in vial. Percent of participants with number of Activated Clotting Time near normal domain (70-120) second. Timepoint: 5 minutes after the end of protamine injection. Method of measurement: Activated Clotting Time assessment with Coagulometer device according to second. Percent of abnormal bleeding. Timepoint: Drainage assessment of the drains and chest tubes 12 hours and 36 hours after the end of surgery. Method of measurement: Drainage assessment of the drains and chest tubes according to cubic centimeter. Esfahan University of Medical Sciences Approved 2022-05-25 Ethics committee of Isfahan University of Medical Sciences Chamran Hospital, Salman-E-Farsi Street Isfahan Isfehan Iran (Islamic Republic of)