High-Dose Deferoxamine in Intracerebral Hemorrhage


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Trial ID: NCT01662895


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

Stanford Investigator(s)

Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery


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

   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.


drug: Deferoxamine

drug: Normal saline


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Stephanie Kemp
(650) 723-4481