: Evaluation of the early effect of erythropoietin and testosterone in patients with neurological damage

Evaluation of the early effect of erythropoietin and testosterone in patients with neurological damage

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 60 patients. In order to randomize, the block randomization method will be used.

Patients referred to Hazrat Rasool Hospital who have neurological damage caused by trauma will be enrolled in the study. Patients will be randomly divided into two groups based on blocks of 4. A total of 60 patients will be examined. Patients and the data analyst will be blinded.

Patients referred to Hazrat Rasool Hospital who have neurological damage caused by trauma will be enrolled in the study. Inclusion criteria: Patients over 12 years, Patients with neurological damage caused by brain trauma on radiograph or electroencephalogram with a GCS score of less than 9 Exclusion criteria: 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.

Intervention group: Patients will receive erythropoietin+testosterone (56,000 units subcutaneously) once a week for a maximum of three doses. Control group: Patients will receive placebo (0.9% sodium chloride subcutaneously) once weekly for a maximum of three doses.

level of consciousness; Deep venous thrombosis of the lower limb; Frequency of deaths

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.

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.