The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this trial is to study the effects of deferoxamine on brain or intracranial hemorrhage (ICH). This trial also will help researchers learn more about the safety of the drug.

ICH occurs when a blood vessel in the brain bursts open. This causes blood to leak into the brain and may lead to a hemorrhagic stroke. A hemorrhagic stroke occurs when blood flow to a part of the brain stops. The blood in the brain also contains iron, which damages the brain.

The focus of this multi-center, double-blind, placebo-controlled study is to evaluate deferoxamine mesylate, or deferoxamine. Deferoxamine has been approved by the FDA for use in other diseases to remove excess iron from the body. It combines with iron in the bloodstream. The combination of iron and deferoxamine is then removed from the body by the kidneys.

In this study, scientists will test if removal of iron from the brain after ICH will reduce the effects of the hemorrhage. The main purpose of this study is to examine how deferoxamine affects ICH. Scientists will specifically look at a person’s ability to function and think well after ICH. Researchers also will learn more about the safety of the study drug.

A total of 294 people will be enrolled in this study at sites in the U.S. and Canada. Participants will be randomized to receive either deferoxamine mesylate or saline placebo for 3 consecutive days. Treatment will begin within 24 hours after ICH symptom onset. All participants will be followed for 6 months and will receive standard of care therapy while participating in the study. Follow-up will include 2 in-person study visits and 2 study phone calls.

Study duration for participants is about 6 months.

Eligibility Criteria:

INCLUSION

  • Age ≥ 18 and ≤ 80 years
  • Diagnosis of ICH is confirmed by brain computed tomography (CT) scan
  • NIHSS score ≥6 and GCS >6 upon presentation
  • Functional independence prior to ICH

EXCLUSION

  • Previous chelation therapy or known hypersensitivity to deferoxamine (DFO) products
  • Known severe iron deficiency anemia
  • Abnormal renal function
  • Planned surgical evacuation of ICH prior to administration of study drug
  • Suspected secondary ICH related to tumor, 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 NIH Stroke Scale (NIHSS)
  • Pre-existing disability
  • Coagulopathy; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban or apixaban), or low-molecular-weight heparin
  • Persons with confirmed aspiration, pneumonia, or evident bilateral pulmonary infiltrates on chest x-ray or CT scan prior to enrollment
  • Persons with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use (chronic or intermittent) of inhaled O2 at home
  • Fraction of inspired oxygen (FiO2) >0.35 (>4 L/min) prior to enrollment
  • Sepsis; Systemic Inflammatory Response Syndrome; Respiratory rate >20 or PaCo2 <32 mmHg; white blood cell (WBC) >12, <4, or bands >10%); or shock [systolic blood pressure (SBP) <90 mmHg] at presentation
  • The presence of 4 or more of the following risk modifiers for Acute Respiratory Distress Syndrome (ARDS) prior to enrollment: Tachypnea (respiratory rate >30); Pulse Oximetry (SpO2) <95%; Obesity (BMI >30); Acidosis (pH <7.35); Hypoalbuminemia (albumin <3.5 g/dL); or concurrent use of chemotherapy
  • Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine
  • Persons with heart failure taking > 500 mg of vitamin C daily
  • Known severe hearing loss
  • Pregnancy or breastfeeding
  • Positive drug screen, alcoholism, or drug dependency
  • Any condition which, in the judgment of the investigator, might increase the risk to the patient
  • Life expectancy of less than 90 days due to co-morbid conditions
  • Concurrent participation in another research protocol for investigation of another experimental therapy
  • Indication that a new Do Not Resuscitate (DNR) or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Location:

Multiple U.S. Locations