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Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

Primary Purpose

Intracerebral Hemorrhage

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Deferoxamine Mesylate
Placebo (for Deferoxamine Mesylate)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Brain hemorrhage, Cerebral hemorrhage, Bleeding in the brain, Deferoxamine, iDEF trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital / Barrow Neurological Institute
  • Stanford University Medical Center
  • San Francisco General Hospital
  • Yale New Haven Hospital
  • University of Florida
  • Loyola University Medical Center
  • RUSH University Medical Center
  • University of Iowa Medical Center
  • Johns Hopkins Hospital
  • Beth Israel Deaconess Medical Center
  • UMass Memorial Medical Center
  • Henry Ford Hospital
  • Columbia University
  • Mount Sinai Hospital
  • NYU Langone Medical Center
  • Weill Medical College of Cornell University
  • University of North Carolina Medical Center
  • Duke University Medical Center
  • University Hospital Case Medical Center
  • The Ohio State University Medical Center
  • Oregon Health & Science University Medical Center
  • University of Pennsylvania Medical Center
  • Rhode Island Hospital
  • Medical University of South Carolina
  • University of Texas Health Sciences Center
  • Foothills Hospital - University of Calgary
  • University of Alberta - Mackenzie Health Sciences Centre
  • CHU de Québec - Hôpital de l'Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Deferoxamine Mesylate

Normal Saline

Arm Description

Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days

Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days

Outcomes

Primary Outcome Measures

Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Number of Subjects Experiencing Serious Adverse Events
Number of subjects experiencing Serious adverse events at any time from randomization through day 90
Number of Subjects With Serious Adverse Events Within 7 Days
Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization

Secondary Outcome Measures

Proportion of Patients With mRS Score 0-3 at 90 Days
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability.
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows
Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows.

Full Information

First Posted
June 25, 2014
Last Updated
May 29, 2019
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital, University of Massachusetts, Worcester, University of Pennsylvania, Johns Hopkins University, Duke University, University of North Carolina, University of Florida, Henry Ford Hospital, Ohio State University, St. Joseph's Hospital and Medical Center, Phoenix, University of California, San Francisco, Oregon Health and Science University, Yale New Haven Health System Center for Healthcare Solutions, University of Iowa, Hartford Hospital, The University of Texas Health Science Center, Houston, Rhode Island Hospital, Stanford University, University of Washington, University of Calgary, Hopital de l'Enfant-Jesus, University of Alberta, Rush University Medical Center, University Hospitals Cleveland Medical Center, Columbia University, Weill Medical College of Cornell University, NYU Langone Health, Mount Sinai Hospital, New York, Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT02175225
Brief Title
Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
Official Title
Study of Deferoxamine Mesylate in Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
February 10, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Brain hemorrhage, Cerebral hemorrhage, Bleeding in the brain, Deferoxamine, iDEF trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deferoxamine Mesylate
Arm Type
Experimental
Arm Description
Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Deferoxamine Mesylate
Intervention Type
Drug
Intervention Name(s)
Placebo (for Deferoxamine Mesylate)
Primary Outcome Measure Information:
Title
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days
Description
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Time Frame
90 days
Title
Number of Subjects Experiencing Serious Adverse Events
Description
Number of subjects experiencing Serious adverse events at any time from randomization through day 90
Time Frame
90 days
Title
Number of Subjects With Serious Adverse Events Within 7 Days
Description
Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Proportion of Patients With mRS Score 0-3 at 90 Days
Description
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability.
Time Frame
90 days
Title
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days
Description
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Time Frame
180 days
Title
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days
Description
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Time Frame
180 days
Title
Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows
Description
Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Ordinal Distribution of Scores on mRS at Day 90
Description
The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined.
Time Frame
90 days
Title
Ordinal Distribution of Scores on mRS at 180 Days
Description
The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined.
Time Frame
180 days
Title
Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)
Description
Adverse event of special interest: anaphylaxis at any time during the study infusion
Time Frame
during the study infusion
Title
Adverse Event of Special Interest: Number of Patients With Hypotension
Description
Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes
Time Frame
during the study infusion
Title
Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes
Description
Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion
Time Frame
after initiation of study infusion
Title
Adverse Event of Special Interest: Number of Patients With Respiratory Compromise
Description
Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge [whichever was earlier]
Time Frame
7 days
Title
Number of Patients With Symptomatic Cerebral Edema
Description
Edema accompanied by an unexplained increase of more than four points on the US National Institutes of Health Stroke Scale or a decrease of more than two points in Glasgow Coma Scale score during the first week after the intracerebral haemorrhage.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy Selim, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Hospital / Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
Country
United States
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Loyola University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
RUSH University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa Medical Center
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
Country
United States
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University Hospital Case Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Oregon Health & Science University Medical Center
City
Portland
State/Province
Oregon
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
University of Texas Health Sciences Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Foothills Hospital - University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta - Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
CHU de Québec - Hôpital de l'Enfant-Jésus
City
Québec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23943316
Citation
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.
Results Reference
background
PubMed Identifier
21868742
Citation
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.
Results Reference
background
PubMed Identifier
19064798
Citation
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.
Results Reference
background
PubMed Identifier
24187595
Citation
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.
Results Reference
background
PubMed Identifier
24172580
Citation
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.
Results Reference
background
PubMed Identifier
20044521
Citation
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.
Results Reference
background
PubMed Identifier
24366522
Citation
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.
Results Reference
background
PubMed Identifier
35676589
Citation
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.
Results Reference
derived
PubMed Identifier
35306827
Citation
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.
Results Reference
derived
PubMed Identifier
34789008
Citation
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.
Results Reference
derived
PubMed Identifier
33758069
Citation
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.
Results Reference
derived
PubMed Identifier
30898550
Citation
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.
Results Reference
derived

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Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

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