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IRCT20150704023046N4 IRCT 2020-02-08 Ahvaz University of Medical Sciences Effect of fibrinogen compared to fresh frozen plasma on patients with hemorrhagic shock Comparison of the fibrinogen and fresh frozen plasma efficacy in patients outcome with hemorrhagic shock due to multiple trauma 2019-03-21 anticipated 30 Complete https://irct.ir/trial/35729 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Accidental randomization was done using randomized blocking method in which subjects were assigned to three main groups (two intervention groups and one control group) (each group was 10) and the volume of blocks was 4 Which was determined through the PROC PLAN in SAS 9.2 software, Blinding description: Blindness in this study is that after evaluating an emergency medicine practitioner and determining the patient's placement in one of our three study groups, the injectable drug will be given to the nurse of the CPR department, and then the order of assessment of the patient's vital signs will be researcher Emergency medicine), which has no information on how to describe the patient's placement and type of injectable medicine, is given according to the protocol. 3 Condition 1: Hemorrhagic shock. Condition 2: Hypovolemic shock. Intervention 1: Intervention group: Patients receiving Packed Cell and Frozen Fresh Plasma in proportion (FFP: 1: 1 PRbc Ratio). Intervention is performed for each patient at one time in the emergency CPR room. Each packed cell is approximately 200-250 cc and each frozen plasma unit is 200-300 cc. Intervention 2: Intervention group: Patients receiving Packed Cell and Fibrinogen. The amount of fibrinogen injection will be 70 mg / kg. The fibrinogen vial is made in Germany and will be provided by Avin Daru Company in Iran. Interventions are performed for each patient at one time and in the emergency CPR room. Intervention 3: Control group: Patients receiving Packed Cell. The Packed Cell available at the Blood Bank Center of the studied hospitals was used. The size of each Packed Cell is approximately 200-250 cc. The number of Packed Cell varies depending on the patient's needs and clinical conditions. Intervention is performed for each patient at one time and in the emergency CPR room. Yes - There is a plan to make this available What will be shared: Only part of the information, such as information on the main outcome or the like, can be shared. When: Start the access period 6 months after printing the results To whom: Researchers working in academic and academic institutions and industry-related people Conditions: Solely for the sake of scientific use and only with the permission of the owners of the design Where to obtain: Responsible person is responsible for studying and by email registered on the site How to obtain: So coordinate with the responsible person responsible for the study through email registered on the site Comments:
public Ehsan Karimpour
Ahvaz Jundishapur University of Medical Sciences - Golestan
Ahwaz Iran (Islamic Republic of) 61357-15794 +98 61 3222 2818 Dr.EhsanKarimpour@Gmail.Com Ahvaz University of Medical Sciences scientific Meysam Moezi
Ahvaz Jundishapur University of Medical Sciences - Golestan
Ahwaz Iran (Islamic Republic of) 61357-15794 +98 61 3222 2818 Dr.EhsanKarimpour@Gmail.Com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with hemorrhagic shock caused by multiple trauma Age> 14 years Systolic blood pressure <90 mm Hg Significant chance of bleeding Evidence of intra abdominal bleeding Clinical judgment of the doctor about the receipt of blood products 14 years no limit Both Pregnancy Patients with known coagulopathy Using anti-coagulant and anti-platelet drugs Other causes of shock, such as neurogenic shock Previous history of blood product in the last 6 months Patients are severely ill, whose priority is to preserve the patient's health Dissatisfaction with the patient or patient companions to participate in the study R58 R57.1 Hemorrhage, not elsewhere classified Hypovolemic shock Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving Packed Cell and Frozen Fresh Plasma in proportion (FFP: 1: 1 PRbc Ratio). Intervention is performed for each patient at one time in the emergency CPR room. Each packed cell is approximately 200-250 cc and each frozen plasma unit is 200-300 cc. Intervention group: Patients receiving Packed Cell and Fibrinogen. The amount of fibrinogen injection will be 70 mg / kg. The fibrinogen vial is made in Germany and will be provided by Avin Daru Company in Iran. Interventions are performed for each patient at one time and in the emergency CPR room. Control group: Patients receiving Packed Cell. The Packed Cell available at the Blood Bank Center of the studied hospitals was used. The size of each Packed Cell is approximately 200-250 cc. The number of Packed Cell varies depending on the patient's needs and clinical conditions. Intervention is performed for each patient at one time and in the emergency CPR room. Blood Pressure. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: Clinical examination and assessment of vital signs by cardiac monitoring and pulse oximetry located in the cardiopulmonary resuscitation room. Oxygenation index. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: pulse oximetry located in the cardiopulmonary resuscitation room. PH level. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: By taking arterial blood samples and evaluating arterial blood gas by laboratory tests. Duration of admission. Timepoint: When ordering a patient's discharge or issuing a death certificate. Method of measurement: Clinical examination and evaluation of patient records. Ahvaz University of Medical Sciences Approved 2018-08-29 The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahwaz Jundishapur Research and Technology Dept, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)