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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220220054079N1
Enrollment
68
Registered
2022-12-07
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe traumatic brain injury. Diffuse traumatic brain injury

Interventions

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
it will be identical to the intervention drug in amount, shape, color, and packaging.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor
Afa Chemi Pharmaceutical Company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Scale. Timepoint: At the time of discharge, three and six months after the intervention. Method of measurement: Glasgow Outcome Scale.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Eghlidos

Shiraz University of Medical Sciences

eghlidos.zahra@gmail.com+98 71 3636 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026