High-Dose Deferoxamine in Intracerebral Hemorrhage

• Status: Terminated
• Trial end date: 2018-05-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Dalhousie University; Duke University; Hartford Hospital; Henry Ford Hospital; Hopital de l'Enfant-Jesus; Johns Hopkins University; Massachusetts General Hospital; Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); Ohio State University; Oregon Health and Science University; Rhode Island Hospital; St. Joseph's Hospital and Medical Center, Phoenix; Stanford University; The Cleveland Clinic; The University of Texas Health Science Center, Houston; Tufts Medical Center; University of Alberta; University of Calgary; University of California, San Francisco; University of Florida; University of Iowa; University of Maryland; University of Maryland, College Park; University of Massachusetts, Worcester; University of North Carolina; University of Pennsylvania; University of Virginia; University of Washington; Yale New Haven Hospital
• Treatments: Deferoxamine

Criteria

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.