Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

Completed · Phase 2 · Has a placebo group

Conditions studied: Intracerebral Hemorrhage

In brief

The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients with brain hemorrhage. 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.

Key facts

Study ID

NCT02175225

Run by

Beth Israel Deaconess Medical Center

People needed

294

Starts

2014-10-01

Expected to finish

2018-05-30

Last updated by the study team

2019-05-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 and ≤ 80 years
• The diagnosis of ICH is confirmed by brain CT scan
• NIHSS score ≥6 and GCS >6 upon presentation
• The first dose of the study drug is expected to be administered within 24h of ICH symptom onset
• Functional independence prior to ICH, defined as pre-ICH mRS ≤1
• Signed and dated informed consent is obtained.

You may not qualify if…

• Previous chelation therapy or known hypersensitivity to DFO products
• Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions)
• Abnormal renal function, defined as serum creatinine >2 mg/dL
• Planned surgical evacuation of ICH prior to administration of study drug (placement of a catheter for ventricular drainage is not a contraindication to enrollment)
• SUSPECTED secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
• Infratentorial hemorrhage
• Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing)
• 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)
• Pre-existing disability, defined as pre-ICH mRS ≥2
• 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
• Patients with confirmed aspiration, pneumonia, or evident bilateral pulmonary infiltrates on chest x-ray or CT scan prior to enrollment
• Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use (chronic or intermittent) of inhaled O2 at home
• FiO2 >0.35 (>4 L/min) prior to enrollment
• Sepsis (present source of infection ± lactic acidosis); Systemic Inflammatory Response Syndrome (Temp >100.4F or <96.8F; Heart rate >90; Respiratory rate >20 or PaCo2 <32 mmHg; WBC >12, <4, or bands >10%); or shock (SBP <90 mmHg) at presentation
• The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:
• Tachypnea (respiratory rate >30)
• SpO2 <95%
• Obesity (BMI >30)
• Acidosis (pH <7.35)
• Hypoalbuminemia (albumin <3.5 g/dL)
• Concurrent use of chemotherapy
• Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine
• Patients with heart failure taking > 500 mg of vitamin C daily
• Known severe hearing loss
• Known pregnancy, or positive pregnancy test, or breastfeeding

Where it is running

• St. Joseph's Hospital / Barrow Neurological Institute — Phoenix, Arizona, United States
• Stanford University Medical Center — Palo Alto, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida — Jacksonville, Florida, United States
• Loyola University Medical Center — Chicago, Illinois, United States
• RUSH University Medical Center — Chicago, Illinois, United States
• University of Iowa Medical Center — Iowa City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Columbia University — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospital Case Medical Center — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University Medical Center — Portland, Oregon, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Sciences Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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