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IRCT20200109046064N1 IRCT 2020-02-11 Iran University of Medical Sciences Effect of fibrinogen on bleeding during pelvic surgery The Effect of Prophylactic Fibrinogen Infusion on intraoperative bleeding during Pelvic Surgery 2020-02-20 anticipated 42 Complete https://irct.ir/trial/44925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table and quadruple blocks, the following states are obtained and individuals in group A receive fibrinogen and those in group B receive placebo. The above cases include ABAB, AABB, BAAB, BABA, BBAA, ABBA, which are put together by four blocks of states that are completely random and are randomly divided into patients, Blinding description: To blind and hide the specimens, a special code was written for each patient in a sealed envelope that only by a researcher opened the envelope just prior to attempting to anesthetize the patient in complete confidentiality. 3 Pelvic Surgery. Intervention 1: Intervention group: Before surgery, one gram of prophylactic fibrinogen infusion (made by the Marburg factory in Germany) is performed in 50 ml of normal saline within five minutes after induction of anesthesia. Intervention 2: Control group: Before surgery, normal saline infusion is performed. Yes - There is a plan to make this available What will be shared: All potential data is shared after unidentifiable people. When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: There are no special conditions. Where to obtain: Majid Charousaie How to obtain: After reviewing the applicant's request, it will be sent to him. Comments:
public Majid Charousaie
Firoozgar Hospital, Afarin Ave, Karim Khan Street, Valiasr Square
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 8214 1600 drch128@gmail.com Iran University of Medical Sciences scientific Majid Charousaie
Firoozgar Hospital, Afarin Ave, Karim Khan Street, Valiasr Square
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ 009882141600 drch128@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients candidate for non-emergency pelvic surgery undergoing general anesthesia Satisfaction with study participation Age between 18-60 BMI<30 The preoperative fibrinogen level should be 2-4 g/lit 18 years 60 years Both cardiovascular, liver, kidney, coagulation and hypertension disorders, diabetes and tumors in surgical areas. History of use the Beta-Blocker, Calcium Blocker, Digoxin, Tricyclic Antidepressants, Anti-Coagulant and Clonidine A history of alcohol, drug and drug abuse S32.7 Multiple fractures of lumbar spine and pelvis Treatment - Drugs Treatment - Drugs Intervention group: Before surgery, one gram of prophylactic fibrinogen infusion (made by the Marburg factory in Germany) is performed in 50 ml of normal saline within five minutes after induction of anesthesia. Control group: Before surgery, normal saline infusion is performed. Plasma fibrinogen. Timepoint: Before and after surgery. Method of measurement: Based on the patient's blood laboratory results. Iran University of Medical Sciences Approved 2018-04-29 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)