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IRCT20120910010800N3 IRCT 2022-04-05 Shahid Beheshti University of Medical Sciences Determining the preventive effect of venous fibrinogen on the amount of bleeding during hip arthroplasty surgery Determining the preventive effect of venous fibrinogen on the amount of bleeding during hip arthroplasty surgery 2022-05-22 anticipated 110 Complete https://irct.ir/trial/62685 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are grouped among the people referring to the operating room of Imam Hossein Hospital (AS) for hip arthroplasty surgery by simple randomization method using coin toss. In such a way that the selection of the case is done in case of tap and the selection of control is done in case of line, Blinding description: Before anesthesia, the other anesthesia technician selects one of the syringes containing fibrinogen (case group) or placebo (control group) for the patient without the knowledge of the anesthesiologist and the patient. After general anesthesia, the infusion is started for all patients. After the surgery, the questionnaire is delivered to the first technician. 3 Total hip arthroplasty. Intervention 1: Intervention group: After induction of anesthesia, one vial of fibrinogen powder equivalent to one gram of it under the brand name HAEMOCOMPLETTAN P Injection, Powder 1 g made by CSL BEHRING company in Germany with 50 ml of distilled water to minimize foam production in the vial It is diluted. The entire amount is drawn into a 50 ml syringe and then injected intravenously using an infusion pump over ten-minutes in a single dose. Intervention 2: Control group: After induction of anesthesia, 50 ml of distilled water is drawn in a 50 ml syringe and then injected intravenously using an infusion pump for ten minutes as a single dose. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: One year after the publication of the article. To whom: All jobs Conditions: All non-personal patient information (anonymously) can be accessed by contacting the responsible author. Where to obtain: email to: drdariushabtahi@yahoo.com How to obtain: Sending email and review by the responsible author. Comments:
public Dariush Abtahi
Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 009821277567840 drdariushabtahi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dariush Abtahi
Shahid Madani St.
Tehran Iran (Islamic Republic of) 1617763141 009812277567840 drdariushabtahi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) over than 18 years old Consent to the study 18 years no limit Both Drug abuse Existence of uncontrolled underlying disease History of any previous surgery within the field of the current operation Recent history of coagulation disease Taking drugs that affect blood clotting before hospitalization Treatment - Drugs Placebo Intervention group: After induction of anesthesia, one vial of fibrinogen powder equivalent to one gram of it under the brand name HAEMOCOMPLETTAN P Injection, Powder 1 g made by CSL BEHRING company in Germany with 50 ml of distilled water to minimize foam production in the vial It is diluted. The entire amount is drawn into a 50 ml syringe and then injected intravenously using an infusion pump over ten-minutes in a single dose. Control group: After induction of anesthesia, 50 ml of distilled water is drawn in a 50 ml syringe and then injected intravenously using an infusion pump for ten minutes as a single dose. Bleeding during surgery. Timepoint: End of surgery. Method of measurement: The amount of bleeding during the operation will be measured by gas count and suction measurement, as well as the estimation of bleeding at the operation site by an anesthesiologist. Number of units of injected blood products. Timepoint: Up to 24 hours after surgery. Method of measurement: Registration of blood products injection sheet. Shahid Beheshti University of Medical Sciences Approved 2022-03-13 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University Emam Hossein Hospital, Shahid Madani St. Tehran Tehran Iran (Islamic Republic of)