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