Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

• Status: Completed
• Trial end date: 2018-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Columbia University; Duke University; Hartford Hospital; Henry Ford Hospital; Hopital de l'Enfant-Jesus; Johns Hopkins University; Loyola University; Massachusetts General Hospital; Medical University of South Carolina; Mount Sinai Hospital, New York; National Institute of Neurological Disorders and Stroke (NINDS); New York University Langone Medical Center; NYU Langone Health; Ohio State University; Oregon Health and Science University; Rhode Island Hospital; Rush University Medical Center; St. Joseph's Hospital and Medical Center, Phoenix; Stanford University; The University of Texas Health Science Center, Houston; University Hospitals Cleveland Medical Center; University of Alberta; University of Calgary; University of California, San Francisco; University of Florida; University of Iowa; University of Massachusetts, Worcester; University of North Carolina; University of Pennsylvania; University of Washington; Weill Medical College of Cornell University; Yale New Haven Health System Center for Healthcare Solutions
• Treatments: Deferoxamine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

1. Tachypnea (respiratory rate >30)

2. SpO2 <95%

3. Obesity (BMI >30)

4. Acidosis (pH <7.35)

5. Hypoalbuminemia (albumin <3.5 g/dL)

6. 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

• Positive drug screen for cocaine upon presentation

• 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

• Any condition which, in the judgement 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 DNR or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization