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IRCT20220220054079N1 IRCT 2022-12-07 Shiraz University of Medical Sciences Deferoxamine in severe traumatic brain injury Effect of deferoxamine injection on the Glasgow Outcome Scale in patients with severe traumatic brain injury: a double-blind, randomized controlled clinical trial 2022-12-22 anticipated 68 Complete https://irct.ir/trial/62086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will randomly divide eligible patients into two groups in a 1:1 ratio: intervention (group A) and control (group B). Block randomization will be performed with four patients in each block using an online randomization tool, and block sequences will be ABBA, AABB, BBAA, BABA, ABAB, and BAAB. The principal researcher -who is not involved in patient evaluation and data analysis- will perform the randomization and conceal the allocation sequence from other investigators and patients, Blinding description: The faculty of Pharmacy, Shiraz university of medical sciences, will prepare the placebo drug according to the intervention drug (same color, amount, and packaging). The study will be double-blind. For this purpose, the study drugs (deferoxamine and placebo) will be identically packed; the principal researcher will put number codes on the packages and he will keep these codes confidential. He will also perform the randomization but has no role in prescribing the drugs, as well as recording and analyzing the patients' information. Patients will be informed about the study's details and purpose, but they do not know which medication they will receive. So, patients, physicians, and analysts are blinded to treatment groups. 3 Severe traumatic brain injury. Intervention 1: Intervention group: severe traumatic brain injury patients receiving 20 mg/kg per day deferoxamine for 7 consecutive days and as a 24-hour intravenous infusion. Intervention 2: Control group: receiving 20 mg/kg per day placebo drug for 7 consecutive days as and as a 24-hour intravenous infusion. The placebo is prepared by the faculty of Pharmacy, Shiraz university of medical sciences; it will be identical to the intervention drug in amount, shape, color, and packaging. 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 Due to the unpredictability of the situation
public Zahra Eghlidos
Emtiyaz hospital, Chamran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3636 4001 eghlidos.zahra@gmail.com Shiraz University of Medical Sciences scientific Gholamreza Vadiee
Emtiyaz hospital, Chamran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3636 4001 gholamrezavadiee@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with severe traumatic brain injury Patients with pure traumatic brain injury: having a score of less and equal to 3 on the Brain Abbreviated Injury scale; and a score of less than 3 on the Extracranial Abbreviated Injury scale 18 years 65 years Both Allergy to deferoxamine mesylate Serum creatinine more than 2 mg/dL Hemoglobin less than 7 g/L, or patients requiring transfusion therapy A Glasgow Coma Scale score of 3 or 4 with bilateral fixed and dilated pupils A known history of intracranial diseases A known history of thrombocytopenia (platelet count less than 50×109/L) Concurrent use of anti‐coagulant or anti‐platelet agents or history of coagulation disorders (international normalized ratio more than 1.4) Concurrent use of iron supplements or prochlorperazine Impaired hearing Pregnant or lactating women History of cardiopulmonary arrest and resuscitation Blood disorders (e.g. thalassemia, iron deficiency anemia) GFR less than 50 ml/min History of heart failure History of liver disease S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo Intervention group: severe traumatic brain injury patients receiving 20 mg/kg per day deferoxamine for 7 consecutive days and as a 24-hour intravenous infusion Control group: receiving 20 mg/kg per day placebo drug for 7 consecutive days as and as a 24-hour intravenous infusion. The placebo is prepared by the faculty of Pharmacy, Shiraz university of medical sciences; it will be identical to the intervention drug in amount, shape, color, and packaging Glasgow Outcome Scale. Timepoint: At the time of discharge, three and six months after the intervention. Method of measurement: Glasgow Outcome Scale. Duration of intensive care unit admission. Timepoint: From the admission date to discharge date from the intensive care unit. Method of measurement: Number of days. Duration of hospital admission. Timepoint: From the admission date to discharge date from the hospital. Method of measurement: Number of days. Afa Chemi Pharmaceutical Company Shiraz University of Medical Sciences Afa Chemi Pharmaceutical Company Approved 2022-01-10 Ethics committee of Shiraz University of Medical Sciences Emtiyaz hospital, Chamran Blvd, Shiraz Shiraz Fars Iran (Islamic Republic of)