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IRCT20240617062155N1 IRCT 2024-08-10 Arak University of Medical Sciences effectiveness of phenytoin and Levetiracetam and valproic acid in prevention of seizure of brain hemorrahage Comparison of the effectiveness of phenytoin and Levetiracetam and valproic acid in prevention of seizure of post traumatic brain hemorrahage 2024-08-01 anticipated 225 Complete https://irct.ir/trial/77557 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be done using block randomization method. In this way, 225 blocks of 3 were created randomly using randomization.com online software by the plan's statistical consultant and sealed in 225 envelopes with aluminum cover and numbered in the order of creation. Then, during the implementation of the plan, the created sequences will be removed from the envelopes and the patients will be assigned to groups A, B and C based on the sequence of each block, Blinding description: Patients will be assigned to each treatment based on block randomization method.The study procedure and the requirement to receive an anticonvulsant drug after severe traumatic brain injury, which is one of the 3 injectable drugs available in Iran which are also the subject of our study, will be explained to patients or their legal guardians, and informed consent will be obtained. However, the patients or their legal guardian will not be aware of the type of drug received (out of the 3 drugs). Additionally, the medical intern, who is responsible for collecting data, will not be aware of the drug received and will recognize them into groups A, B, or C ; the project manager and the data analyst will be aware of the type of drug received by the patients. 3 traumatic intracerebral haemorrhage. Intervention 1: Intervention group 1: In this group, the patients are treated with the anticonvulsant drug phenytoin (Caspian-Iran) with a loading dose of 20 mg/kg and injection within one hour and a maintenance dose of 5 mg/kg every day, which the patients first receive injectable drug for 24 to 48 hours and then They receive oral drug. Phenytoin is taken from Caspian Tamin-Iran pharmaceutical company. It is one of the three common anti-seizure medications used in Iran to prevent seizures caused by traumatic brain injury. Intervention 2: Intervention group 2: In this group, patients are treated with the anticonvulsant drug Levetiracetam (Arang-Iran) with a loading dose of 20 mg/kg and an injection within one hour and a maintenance dose of 10 to 20 mg/kg every day. They receive for 24-48 hours injectable and then oral medicine. Levetiracetam is taken from Arang-Iran Daro Darman pharmaceutical company . It is one of the three common anti-seizure medications used in Iran to prevent seizures caused by traumatic brain injury. Intervention 3: Intervention group 3: In this group, 15 mg/kg of the anticonvulsant drug sodium valproate (Arang-Iran) injection is first prescribed for patients, and the maintenance dose is 15 mg/kg in 2 to 3 divided doses every day. Patients first receive injectable medicine for 24 to 48 hours and then orally. The sodium valproate is taken from Daro Derman Arang-Iran pharmaceutical company.It is one of the three common anti-seizure medications used in Iran to prevent seizures caused by traumatic brain injury. 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 No more information.
public Benyamin Beyrami
Payambar-e-azam complex, Sardasht Town
Arak Iran (Islamic Republic of) 3814957558 +98 86 3314 4712 benyamin.medicine@gmail.com Arak University of Medical Sciences scientific Benyamin Beyrami
Payambar-e-azam complex, Sardasht Town
Arak Iran (Islamic Republic of) 3814957558 +98 86 3314 4712 benyamin.medicine@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Head trauma requiring prophylactic anticonvulsant treatment no limit no limit Both Pregnancy History of epilepsy Allergy to the studied drugs S06.3 Focal traumatic brain injury Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, the patients are treated with the anticonvulsant drug phenytoin (Caspian-Iran) with a loading dose of 20 mg/kg and injection within one hour and a maintenance dose of 5 mg/kg every day, which the patients first receive injectable drug for 24 to 48 hours and then They receive oral drug. Phenytoin is taken from Caspian Tamin-Iran pharmaceutical company. It is one of the three common anti-seizure medications used in Iran to prevent seizures caused by traumatic brain injury Intervention group 2: In this group, patients are treated with the anticonvulsant drug Levetiracetam (Arang-Iran) with a loading dose of 20 mg/kg and an injection within one hour and a maintenance dose of 10 to 20 mg/kg every day. They receive for 24-48 hours injectable and then oral medicine. Levetiracetam is taken from Arang-Iran Daro Darman pharmaceutical company . It is one of the three common anti-seizure medications used in Iran to prevent seizures caused by traumatic brain injury Intervention group 3: In this group, 15 mg/kg of the anticonvulsant drug sodium valproate (Arang-Iran) injection is first prescribed for patients, and the maintenance dose is 15 mg/kg in 2 to 3 divided doses every day. Patients first receive injectable medicine for 24 to 48 hours and then orally. The sodium valproate is taken from Daro Derman Arang-Iran pharmaceutical company.It is one of the three common anti-seizure medications used in Iran to prevent seizures caused by traumatic brain injury Seizure. Timepoint: The first day to a week after starting the study. Method of measurement: Clinical observation. Arak University of Medical Sciences Approved 2024-05-18 Ethics committee of Arak University of Medical Sciences Payambar-e-azam complex, Sardasht Town Arak Markazi Iran (Islamic Republic of)