High-Dose Deferoxamine in Intracerebral Hemorrhage
Trial ID or NCT#
NCT01662895
Status
RECRUITING
Purpose
The main purpose of this study is to determine whether treatment with deferoxamine mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for brain hemorrhage.
Official Title
Futility Study of Deferoxamine in Intracerebral Hemorrhage
Eligibility Criteria
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Age ≥ 18 and ≤ 80 years 2. The diagnosis of ICH is confirmed by brain CT scan 3. NIHSS score ≥ 6 and GCS > 6 upon presentation 4. The first dose of the study drug can be administered within 24h of ICH symptom onset 5. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1 6. Signed and dated informed consent is obtained.
Exclusion Criteria:
- 1. Previous chelation therapy or known hypersensitivity to DFO products 2. Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions) 3. Abnormal renal function, defined as serum creatinine > 2 mg/dL 4. Planned surgical evacuation of ICH prior to administration of study drug (placement of a catheter for ventricular drainage is not a contraindication to enrollment) 5. Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis 6. Infratentorial hemorrhage 7. Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing) 8. Complete unconsciousness, defined as a score of 3 on item 1a of the NIHSS (Responds only with reflex motor or autonomic effects or totally unresponsive, and flaccid) 9. Pre-existing disability, defined as pre-ICH mRS ≥ 2 10. Coagulopathy - defined as elevated aPTT or INR >1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban), or low-molecular-weight heparin 11. Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine 12. Patients with heart failure taking > 500 mg of vitamin C daily 13. Known severe hearing loss 14. Known pregnancy, or positive pregnancy test, or breastfeeding 15. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause 16. Positive drug screen for cocaine upon presentation 17. Any condition which, in the judgement of the investigator, might increase the risk to the patient 18. Life expectancy of less than 90 days due to comorbid conditions 19. Concurrent participation in another research protocol for investigation of another experimental therapy 20. Indication that a new Do Not Resuscitate (DNR) or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization.
Investigator(s)
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Stroke and vascular neurologist,
Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences
Clinical Professor (By courtesy), Neurosurgery
Contact us to find out if this trial is right for you.
Contact
Stephanie Kemp
(650) 723-4481
View on ClinicalTrials.gov
