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Futility Study of Defroxamine Mesylate in Intracerebral Hemorrhage (iDEF Trial)

Clinical Trial Title: 
iDEF trial (Futility study of defroxamine mesylate in intracerebral hemorrhage).
Clinical Trial Protocol ID: 
14120106
Clinical Trial Investigator Name: 
George A. Lopez, MD, PhD
Clinical Trial Protocol Description: 

The 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 intracerebral hemorrhage. Nationwide, 294 patients will be recruited for this study. At Rush University Medical Center, we expect to recruit 6 patients. Treatment assignment will be assigned randomly between deferoxamine mesylate and a placebo.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are between 18 and 80 years of age.
  • Have a confirmed diagnosis of ICH by brain CT scan.
  • Have an NIHSS score ≥ 6 and GCS > 6 upon presentation.
  • Are able to have the first dose of the study drug administered within 24 hours of ICH symptom onset.
  • Have functional independence prior to ICH, defined as pre-ICH mRS ≤ 1.
  • Have signed and dated informed consent.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had previous chelation therapy or known hypersensitivity to DFO products.
  • Have known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions).
  • Have planned surgical evacuation of ICH prior to administration of study drug (placement of a catheter for ventricular drainage is not a contraindication to enrollment).
  • Have suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis.
  • Have infratentorial hemorrhage.
  • Have irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing)
  • Have 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.)
  • Have a pre-existing disability, defined as pre-ICH mRS ≥ 2.
  • Have 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 apixaban), or low-molecular-weight heparin.
  • Have confirmed aspiration, pneumonia, or evident bilateral pulmonary infiltrates on chest x-ray or CT scan prior to enrollment.
  • Have significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use (chronic or intermittent) of inhaled O2 at home.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Stroke and Cerebrovascular Disease
Contact Phone: 
(312) 942-6731
Contact Name: 
Rebecca Holtz (Study Coordinator)