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IRCT20190422043339N1 IRCT 2021-12-03 Kashan University of Medical Sciences the effect of hemorrhage preventing medication Evaluating the effect of Tranexamic acid on brain contusion and intracerebral hemorrhage in patients with traumatic brain injury (TBI) 2018-09-23 anticipated 80 Complete https://irct.ir/trial/39008 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients (randomization unit is "person") into two groups of 40 people was performed using a random quadruple block method, that is done through the website: www.sealedenvelope.com. In each of the 20 quadruple blocks, 2 patients will receive medication (tranexamic acid) and 2 patients will receive placebo (normal saline). It should be noted that this study is a three-blind study in which physicians and nurses, patients and analyst will be unaware of patient groups, Blinding description: In order to blind the study, syringes containing tranexamic acid and normal saline were pre-drawn, coded, and delivered to the nurses of the relevant wards to inject into the patients under study based on random blocking. None of the physicians and nurses knew the type of medication used for the patients and only one of the implementers of the project knew the medication's code, so that in case of any problem or complication for the patients, he/she would break the medication's code and inform the relevant physician. 3 intracranial hematoma and contusion. Intervention 1: Intervention group: Tranexamic acid made in Iran and Iran Daru Pharmaceutical Company is infused with an initial dose of 1 g per 100 ml of serum within 10 minutes and then infused with a 1 g per 1000 ml maintenance dose of serum for 8 hours. Intervention 2: Control group: The placebo group was infused with normal saline made in Iran and Iran Daru Pharmaceutical Company with an initial dose of 1 g per 100 ml of serum within 10 minutes and then infused with a maintenance dose of 1 g per 1000 ml of serum for 8 hours. Yes - There is a plan to make this available What will be shared: Part of the data can be shared. When: The data will be available, three months after the publication. To whom: Academic researchers, physicians, and medical students, and treatment staff personnel Conditions: Use to improve the treatment process of patients and to plan the same projects Where to obtain: Dr.Esmaeel Fakharian Neurosurgery ward, Shahid Beheshti Hospital, Qotbe ravandi BLVD, Kashan Tel: 00983155540026 efakharian@gmail.com How to obtain: The request will be sent by email, after survey. Comments:
public Esmaeel Fakharian
No.12-Shahed Alley-Shahid Beheshty Avenue-Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 efakharian@gmail.com Kashan University of Medical Sciences scientific Esmaeel Fakharian
No. 12 - Shahed Alley - Shahid Beheshti St. - Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 efakharian@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) All patients over 13 years of age with blunt traumatic brain injury were referred to the emergency department less than 3 hours after the accident. Patients on CT scan have cerebral intraparenchymal hemorrhage upon arrival. 13 years no limit Both Major damage to organs requiring surgical intervention within the first 3 hours Get any medication that disrupts homeostasis S06.3 Focal traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: Tranexamic acid made in Iran and Iran Daru Pharmaceutical Company is infused with an initial dose of 1 g per 100 ml of serum within 10 minutes and then infused with a 1 g per 1000 ml maintenance dose of serum for 8 hours. Control group: The placebo group was infused with normal saline made in Iran and Iran Daru Pharmaceutical Company with an initial dose of 1 g per 100 ml of serum within 10 minutes and then infused with a maintenance dose of 1 g per 1000 ml of serum for 8 hours. Brain contusion. Timepoint: At baseline, 24 and 48 hours after injection. Method of measurement: Brain CT scanning. Intracerebral hemorrhage. Timepoint: At baseline, 24 and 48 hours after injection. Method of measurement: Brain CT scanning. Kashan University of Medical Sciences Approved 2019-03-06 Ethics committee of Kashan University of Medical Sciences School of Medicine, Nurse Blvd., Qotb Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)