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IRCT20170105031787N5 IRCT 2023-05-01 Iran University of Medical Sciences : Evaluation of the early effect of drugs in patients with neurological damage : Evaluation of the early effect of erythropoietin and testosterone in patients with neurological damage 2022-04-21 anticipated 60 Complete https://irct.ir/trial/69511 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups. The randomization tool will be a random sequence generation software called SAS. In addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 4 blocks will be formed and in each block, 2 people from intervention group and 2 people in control group will be placed. A total of 15 blocks will be considered to reach the sample size. The blocks contain numbers, odd numbers represent the intervention group and even numbers represent the control group. Their order will be determined by the software initially. Random allocation concealment will be done using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. the door At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: Patients will be blinded to the type of treatment. To hide similar and identical sera, it was used without drug name label and only with code. Patients will be aware that they will be randomly assigned to one of the two treatment groups, but will not know which treatment will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the data based on groups 1 and 2 and will not know the type of treatment provided in the groups and will be kept blind. 3 Neurological damage caused by brain trauma. Intervention 1: Intervention group: Patients will receive erythropoietin+testosterone (56,000 units subcutaneously) once a week for a maximum of three doses. Patients will receive the first dose of erythropoietin + testosterone in the amount of 40,000 units intravenously within 10 minutes from the onset of symptoms, up to the first 24 hours. After that, the patient will receive 8,000 units of the drug every week. will receive up to 2 times. In fact, a total of 56,000 units of erythropoietin + testosterone will be prescribed for each patient. Intravenous injection of erythropoietin will be done without mixing with other drugs or intravenous fluids. Intervention 2: Control group: Patients will receive placebo (0.9% sodium chloride subcutaneously) once weekly for a maximum of three doses. In the control group, injection will be done with distilled water. In the shortest possible time from the onset of symptoms, up to the first 24 hours, the first dose will be received intravenously within 10 minutes, after that, the patient will receive placebo up to 2 times a week.
public Vahid Ghorbani
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6741575 vahid_ghorbanikj91@yahoo.com Iran University of Medical Sciences scientific Vahid Ghorbani
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6741575 vahid_ghorbanikj91@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients over 12 years Patients with neurological damage caused by brain trauma on radiograph or electroencephalogram with a GCS score of less than 9 12 years 60 years Both Patients over 60 years Patients with fractures of other body parts Patients with fractures of other organs and other problems requiring surgical intervention, such as internal bleeding, rupture of internal organs, severe chest trauma in the medical record or radiographic view. Patients with spinal cord trauma Suffering from a dangerous trauma other than head trauma, including internal bleeding, systolic blood pressure drop less than 80 mmHg, and chest trauma within the first 24 hours. G98.8 Other disorders of nervous system Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive erythropoietin+testosterone (56,000 units subcutaneously) once a week for a maximum of three doses. Patients will receive the first dose of erythropoietin + testosterone in the amount of 40,000 units intravenously within 10 minutes from the onset of symptoms, up to the first 24 hours. After that, the patient will receive 8,000 units of the drug every week. will receive up to 2 times. In fact, a total of 56,000 units of erythropoietin + testosterone will be prescribed for each patient. Intravenous injection of erythropoietin will be done without mixing with other drugs or intravenous fluids Control group: Patients will receive placebo (0.9% sodium chloride subcutaneously) once weekly for a maximum of three doses. In the control group, injection will be done with distilled water. In the shortest possible time from the onset of symptoms, up to the first 24 hours, the first dose will be received intravenously within 10 minutes, after that, the patient will receive placebo up to 2 times a week. Level of consciousness. Timepoint: Before the intervention and 1 week after the intervention. Method of measurement: Glasgow coma criteria. Deep venous thrombosis of the lower limb. Timepoint: After intervention. Method of measurement: Based on ultrasound. Frequency of deaths. Timepoint: After intervention. Method of measurement: Based on the information in the patient's record. Iran University of Medical Sciences Approved 2021-02-23 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)