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IRCT20230901059316N1 IRCT 2024-01-16 Mashhad University of Medical Sciences Investigating the neuroprotective effect of erythropoietin in severe brain trauma Investigating the neuroprotective effect of erythropoietin in patients with severe traumatic brain injury 2024-01-21 anticipated 136 Complete https://irct.ir/trial/72607 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The envelope method is that the envelopes will be prepared and printed and placed inside the envelope by a member of the research team and random numbers with the help of Randomaize.com. The envelope door will be closed and the contents will not be visible from the outside.The purpose of the study is then first explained to the person who has the conditions set forth, and the person, if desired, signs the informed consent form and removes an envelope and then opens it It enters into the intervention or control group based on the contents of the individual envelope, Blinding description: The participant and the nurse do not know about the injection drug that is erythropoietin or placebo. 3 Severe brain trauma. Intervention 1: Intervention group: 100 mg per kilogram of erythropoietin in six hours of arrival and then repeated in the third, sixth, ninth and twelfth days. Intervention 2: Control group: Injection of 10 cc normalsalin 0/9 % in six hours upon arrival and then repeated on the third, sixth, ninth and twelfth days. 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 Data is being collected by me
public Afshin eslamirad
Fadaeian Islam St
Mashhad Iran (Islamic Republic of) 9166637474 +98 51 3859 2121 afshin.eslamirad19122@gmail.com Mashhad University of Medical Sciences scientific Afshin eslamirad
Fadaeian Islam st
Mashhad Iran (Islamic Republic of) 9166637474 +98 51 3859 2121 afshin.eslamirad19122@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with brain trauma with GCS consciousness less than eight who have been treated medically Less than six hours have passed since the patient's trauma 15 years 70 years Both Chronic coagulation disorders Chronic kidney disease History of DVT and pulmonary embolism Treatment - Drugs Placebo Intervention group: 100 mg per kilogram of erythropoietin in six hours of arrival and then repeated in the third, sixth, ninth and twelfth days Control group: Injection of 10 cc normalsalin 0/9 % in six hours upon arrival and then repeated on the third, sixth, ninth and twelfth days. The effect of erythropoietin on increased alertness is measured by periodic examinations based on a score from GCS (Glasgow coma scale). Timepoint: Six weeks and six months after the intervention. Method of measurement: Glasgow coma scale ,Glasgow outcome scale. Mashhad University of Medical Sciences Approved 2023-01-24 Ethics Committee of Mashhad University of Medical Sciences Faculty of Medicine, azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)