Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
NCT ID: NCT02175225
Last Updated: 2019-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
294 participants
INTERVENTIONAL
2014-10-31
2018-05-30
Brief Summary
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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.
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Detailed Description
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Subjects will be randomized to either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a maximum daily dose of 6000 mg/day), or saline placebo, given by IV infusion for 3 consecutive days.
Treatment will be initiated within 24 hours after ICH symptom onset. Randomization will control baseline imbalances associated with baseline ICH score, ICH onset-to-treatment time (OTT), ICH volume, baseline NIHSS score, and warfarin use.
All subjects will be followed for 6 months and will receive standard of care therapy while participating in the study.
Throughout the study, we will continue to assess the safety of DFO. At the conclusion of the study, the proportion of DFO-treated subjects with a good clinical outcome at 3 months (defined as modified Rankin Scale (mRS) score of 0-2) will be compared to the placebo proportion in a futility analysis to determine if it is futile to move DFO forward to Phase III efficacy evaluation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Deferoxamine Mesylate
Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days
Deferoxamine Mesylate
Normal Saline
Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days
Placebo (for Deferoxamine Mesylate)
Interventions
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Deferoxamine Mesylate
Placebo (for Deferoxamine Mesylate)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Massachusetts General Hospital
OTHER
University of Massachusetts, Worcester
OTHER
University of Pennsylvania
OTHER
Johns Hopkins University
OTHER
Duke University
OTHER
University of North Carolina
OTHER
University of Florida
OTHER
Henry Ford Hospital
OTHER
Ohio State University
OTHER
St. Joseph's Hospital and Medical Center, Phoenix
OTHER
University of California, San Francisco
OTHER
Oregon Health and Science University
OTHER
Yale New Haven Health System Center for Healthcare Solutions
OTHER
University of Iowa
OTHER
Hartford Hospital
OTHER
The University of Texas Health Science Center, Houston
OTHER
Rhode Island Hospital
OTHER
Stanford University
OTHER
University of Washington
OTHER
University of Calgary
OTHER
Hopital de l'Enfant-Jesus
OTHER
University of Alberta
OTHER
Rush University Medical Center
OTHER
University Hospitals Cleveland Medical Center
OTHER
Columbia University
OTHER
Weill Medical College of Cornell University
OTHER
NYU Langone Health
OTHER
Mount Sinai Hospital, New York
OTHER
Loyola University
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Magdy Selim
MD, PhD
Principal Investigators
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Magdy Selim, MD, PhD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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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
Foothills Hospital - University of Calgary
Calgary, Alberta, Canada
University of Alberta - Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
CHU de Québec - Hôpital de l'Enfant-Jésus
Québec, , Canada
Countries
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References
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Yeatts SD, Palesch YY, Moy CS, Selim M. High dose deferoxamine in intracerebral hemorrhage (HI-DEF) trial: rationale, design, and methods. Neurocrit Care. 2013 Oct;19(2):257-66. doi: 10.1007/s12028-013-9861-y.
Selim M, Yeatts S, Goldstein JN, Gomes J, Greenberg S, Morgenstern LB, Schlaug G, Torbey M, Waldman B, Xi G, Palesch Y; Deferoxamine Mesylate in Intracerebral Hemorrhage Investigators. Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage. Stroke. 2011 Nov;42(11):3067-74. doi: 10.1161/STROKEAHA.111.617589. Epub 2011 Aug 25.
Selim M. Deferoxamine mesylate: a new hope for intracerebral hemorrhage: from bench to clinical trials. Stroke. 2009 Mar;40(3 Suppl):S90-1. doi: 10.1161/STROKEAHA.108.533125. Epub 2008 Dec 8.
Hatakeyama T, Okauchi M, Hua Y, Keep RF, Xi G. Deferoxamine reduces neuronal death and hematoma lysis after intracerebral hemorrhage in aged rats. Transl Stroke Res. 2013 Oct;4(5):546-53. doi: 10.1007/s12975-013-0270-5.
Xie Q, Gu Y, Hua Y, Liu W, Keep RF, Xi G. Deferoxamine attenuates white matter injury in a piglet intracerebral hemorrhage model. Stroke. 2014 Jan;45(1):290-2. doi: 10.1161/STROKEAHA.113.003033. Epub 2013 Oct 30.
Okauchi M, Hua Y, Keep RF, Morgenstern LB, Schallert T, Xi G. Deferoxamine treatment for intracerebral hemorrhage in aged rats: therapeutic time window and optimal duration. Stroke. 2010 Feb;41(2):375-82. doi: 10.1161/STROKEAHA.109.569830. Epub 2009 Dec 31.
Sonni S, Lioutas VA, Selim MH. New avenues for treatment of intracranial hemorrhage. Curr Treat Options Cardiovasc Med. 2014 Jan;16(1):277. doi: 10.1007/s11936-013-0277-y.
Polymeris AA, Lioutas VA, Incontri D, Soman S, Selim MH; i-DEF Investigators. Evolution of Perihematomal Edema Mean Hounsfield Unit and Its Association with Clinical Outcome in Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Neurocrit Care. 2025 Aug 11. doi: 10.1007/s12028-025-02337-7. Online ahead of print.
Polymeris AA, Lioutas VA, Marchina S, Seiffge DJ, Roh DJ, Poyraz FC, Selim MH; i-DEF Investigators. Hemoglobin and Perihematomal Edema After Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Neurocrit Care. 2025 May 21. doi: 10.1007/s12028-025-02284-3. Online ahead of print.
Lee KH, Lioutas VA, Marchina S, Selim M; iDEF Investigators. The Prognostic Roles of Perihematomal Edema and Ventricular Size in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2022 Oct;37(2):455-462. doi: 10.1007/s12028-022-01532-0. Epub 2022 Jun 8.
Foster L, Robinson L, Yeatts SD, Conwit RA, Shehadah A, Lioutas V, Selim M; i-DEF Investigators. Effect of Deferoxamine on Trajectory of Recovery After Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Stroke. 2022 Jul;53(7):2204-2210. doi: 10.1161/STROKEAHA.121.037298. Epub 2022 Mar 21.
Wei C, Wang J, Foster LD, Yeatts SD, Moy C, Mocco J, Selim M; i-DEF Investigators. Effect of Deferoxamine on Outcome According to Baseline Hematoma Volume: A Post Hoc Analysis of the i-DEF Trial. Stroke. 2022 Apr;53(4):1149-1156. doi: 10.1161/STROKEAHA.121.035421. Epub 2021 Nov 18.
Lun R, Yogendrakumar V, Ramsay T, Shamy M, Fahed R, Selim MH, Dowlatshahi D. Predicting long-term outcomes in acute intracerebral haemorrhage using delayed prognostication scores. Stroke Vasc Neurol. 2021 Dec;6(4):536-541. doi: 10.1136/svn-2020-000656. Epub 2021 Mar 23.
Selim M, Foster LD, Moy CS, Xi G, Hill MD, Morgenstern LB, Greenberg SM, James ML, Singh V, Clark WM, Norton C, Palesch YY, Yeatts SD; i-DEF Investigators. Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2019 May;18(5):428-438. doi: 10.1016/S1474-4422(19)30069-9. Epub 2019 Mar 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012P000005
Identifier Type: -
Identifier Source: org_study_id
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