Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage "DFO In ICH"


Phase 1 Results N/A

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years
2. The diagnosis of ICH is confirmed by brain CT scan.
3. The first dose of the study drug can be administered within 18 hours of ICH symptom onset.
4. Signed and dated informed consent is obtained
5. Stable clinical and neurological status. Patients whose clinical or neurological status significantly deteriorates compared to presentation prior to administration of the study drug will be excluded.

Exclusion Criteria

1. Previous chelation therapy or known hypersensitivity to DFO products
2. Abnormal renal function (serum creatinine > 2 mg/dl)
3. Known severe iron deficiency anemia
4. Planned surgical evacuation of ICH prior to administration of the study drug
5. Patients with suspected secondary ICH related to tumour, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis
6. Evidence of significant shift of midline brain structure (> 10 mm) or herniation on imaging studies.
7. Deep coma (Glasgow Coma Score (GCS) = 3-5) upon presentation
8. Taking iron supplements or prochlorperazine
9. Patients with heart failure taking > 500 mg of vitamin C daily
10. Known hearing impairment
11. Systolic blood pressure < 100 mmHg or diastolic blood pressure < 60 mmHg, confirmed by 3 consecutive readings
12. Significant chronic respiratory insufficiency
13. Known pregnancy (or positive pregnancy test), or breast-feeding
14. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, incompliance, or any other cause.
15. Any condition which, in the judgement of the investigator, might increase the risk to the patient
16. Life expectancy of less than 90 days due to co-morbid conditions
17. Concurrent participation in another research protocol for investigation of another experimental therapy
18. Pre-existing Do Not Resuscitate (DNR) order, or indication that a new DNR order will be implemented within the first 48 hours of hospitalization. -