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IRCT20210415050983N4 IRCT 2023-03-06 Shahid Beheshti University of Medical Sciences Comparison of intravenous tranexamic acid and intravenous fibrinogen on bleeding control in posterior lumbar spine fusion surgery. Comparison of intravenous tranexamic acid and intravenous fibrinogen on bleeding control in posterior lumbar spine fusion surgery. 2023-04-21 anticipated 40 Complete https://irct.ir/trial/68641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer Software R. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached, Blinding description: Forms with numbers 1 and 2 are used in packaged envelopes to group patients, which are given to patients randomly and patients do not know about the envelopes. After entering the envelope operating room by the anesthesiologist in charge of the patient Opened and according to the intervention group, the drug that was prepared in advance is given to the clinical caregiver for injection. The clinical caregiver is not aware of the grouping. The evaluator and recorder of the results and the person analyzing the data are also unaware of the grouping. 3 Lumbar Discopathy. Intervention 1: The group receiving tranexamic acid: 15-30 minutes before surgical incision, 15mg/kg tranexamic acid, which has been diluted with normal saline to a volume of 20 cc, will be administered intravenously. Intervention 2: Fibrinogen receiving group: 15-30 minutes before surgical incision, one gram of Fibrinogen concentrate (Haemocomplettan P; CSL Behring, Pennsylvania) dissolved in 50 ml of distilled water was administered intravenously as described by the manufacturer they receive . Intervention 3: Control group: They receive an equal volume of placebo (normal saline) 30 minutes before surgical incision. 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 Restriction of some magazines to publish
public Sogol Asgari
South Kargar St. Kamali St. Special Loghman Hakim Hospital
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 Drasgari98429@gmail.com Shahid Beheshti University of Medical Sciences scientific Parisa Sezari
Velenjak, Yemen Street, Shahid Shahriari Squareولنجک خیابان یمن میدان شهید شهریاری شهر Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 parisa.sezari@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) No history of drug allergy No history of thromboembolism and coagulation disorders No history of liver or kidney failure No history of heart disease and hypertension ASA I , II Patient consent to participate in the study 18 years 50 years Both use of anticoagulants History of blood disorders and coagulopathy History of liver disease History of chronic kidney disease and creatinine greater than 2mg / dl History of thromboembolic events at any time M51.05 Intervertebral disc disorders with myelopathy, thoracolumbar region Treatment - Drugs Treatment - Drugs Treatment - Drugs The group receiving tranexamic acid: 15-30 minutes before surgical incision, 15mg/kg tranexamic acid, which has been diluted with normal saline to a volume of 20 cc, will be administered intravenously. Fibrinogen receiving group: 15-30 minutes before surgical incision, one gram of Fibrinogen concentrate (Haemocomplettan P; CSL Behring, Pennsylvania) dissolved in 50 ml of distilled water was administered intravenously as described by the manufacturer they receive . Control group: They receive an equal volume of placebo (normal saline) 30 minutes before surgical incision. Determination of intraoperative bleeding in groups receiving tranexamic acid ,fibrinogen and control group. Timepoint: End of surgery. Method of measurement: Bleeding volume during field operation, blood gases, suction. Determining the duration of surgery in the groups receiving tranexamic acid ,fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes. Amount of blood and blood products injected. Timepoint: End of surgery. Method of measurement: The number of units to be injected. Determining the duration of surgery in the groups receiving tranexamic acid ,fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes. Determination of recovery time after reverse dose injection in groups receiving tranexamic acid ,fibrinogen and control group. Timepoint: End of surgery. Method of measurement: hours / minutes. Determining the length of stay in the intensive care unit in the groups receiving tranexamic acid ,fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes. Shahid Beheshti University of Medical Sciences Approved 2022-10-18 Vice for Research and Technology, Shahid Beheshti University of Medical Sciences Velenjak, Yemen Street, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)