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Deferoxamine in severe traumatic brain injury

Phase 3
Recruiting
Conditions
Severe traumatic brain injury.
Diffuse traumatic brain injury
S06.2
Registration Number
IRCT20220220054079N1
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
68
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glasgow Outcome Scale. Timepoint: At the time of discharge, three and six months after the intervention. Method of measurement: Glasgow Outcome Scale.
Secondary Outcome Measures
NameTimeMethod
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.
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