Intracerebral HemorrhagePhase 2NCT02175225
Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
A Phase 2 study testing Deferoxamine Mesylate in people with Intracerebral Hemorrhage, run by Beth Israel Deaconess Medical Center at 28 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Deferoxamine Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Oct 2014to 30 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
Johns Hopkins Hospital
Baltimore, Maryland
Beth Israel Deaconess Medical Center
Boston, Massachusetts
University of North Carolina Medical Center
Chapel Hill, North Carolina
Medical University of South Carolina
Charleston, South Carolina
Loyola University Medical Center
Chicago, Illinois
RUSH University Medical Center
Chicago, Illinois
University Hospital Case Medical Center
Cleveland, Ohio
The Ohio State University Medical Center
Columbus, Ohio
Henry Ford Hospital
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina
University of Texas Health Sciences Center
Houston, Texas
University of Iowa Medical Center
Iowa City, Iowa
University of Florida
Jacksonville, Florida
Yale New Haven Hospital
New Haven, Connecticut
Columbia University
New York, New York
Mount Sinai Hospital
New York, New York
NYU Langone Medical Center
New York, New York
Weill Medical College of Cornell University
New York, New York
Stanford University Medical Center
Palo Alto, California
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania
St. Joseph's Hospital / Barrow Neurological Institute
Phoenix, Arizona
Oregon Health & Science University Medical Center
Portland, Oregon
Rhode Island Hospital
Providence, Rhode Island
San Francisco General Hospital
San Francisco, California
UMass Memorial Medical Center
Worcester, Massachusetts
Canada3 sites
Foothills Hospital - University of Calgary
Calgary, Alberta
University of Alberta - Mackenzie Health Sciences Centre
Edmonton, Alberta
CHU de Québec - Hôpital de l'Enfant-Jésus
Québec
About this study
Official title: Study of Deferoxamine Mesylate in Intracerebral Hemorrhage
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Deferoxamine Mesylate, Placebo (for Deferoxamine Mesylate)
- Keywords
- Brain hemorrhage, Cerebral hemorrhage, Bleeding in the brain, Deferoxamine, iDEF trial
- Medical subject headings
- Cerebral Hemorrhage, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferoxamine MesylateDrug
Placebo (for Deferoxamine Mesylate)Drug
| Study group | Role | What they receive |
|---|---|---|
| Deferoxamine Mesylate | Experimental | Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Receives: Drug: Deferoxamine Mesylate |
| Normal Saline | Placebo comparator | Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Receives: Drug: Placebo (for Deferoxamine Mesylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Number of Subjects Experiencing Serious Adverse Events
Number of subjects experiencing Serious adverse events at any time from randomization through day 90
Measured: 90 days
Number of Subjects With Serious Adverse Events Within 7 Days
Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 90 days
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.
Measured: 180 days
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.
Measured: 180 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startOct 2014
- Primary completion10 Feb 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Magdy Selim, Beth Israel Deaconess Medical Center
- Investigators
- Magdy Selim, MD, PhD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175225
- Sponsor's protocol ID
- 2012P000005
- Other IDs
- U01NS074425
- Status last verified
- May 2019
- First submitted
- 25 Jun 2014
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23943316Selim 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.
PubMed 21868742Selim 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.
PubMed 19064798Hatakeyama 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.
PubMed 24187595Xie 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.
PubMed 24172580Okauchi 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.
PubMed 20044521Sonni 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.
PubMed 24366522Polymeris 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 Dec;43(3):824-833. doi: 10.1007/s12028-025-02337-7. Epub 2025 Aug 11.
PubMed 40789806Polymeris AA, Lioutas VA, Foster LD, Incontri D, Heistand EC, Marchal J, Lazar A, Fischer U, Engelter ST, Seiffge DJ, Yeatts SD, Selim MH. Early neurological improvement with deferoxamine after intracerebral hemorrhage: A post hoc analysis of the i-DEF trial. Int J Stroke. 2025 Dec;20(10):1235-1245. doi: 10.1177/17474930251348088. Epub 2025 May 26.
PubMed 40418029Polymeris 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. 2026 Feb;44(1):64-71. doi: 10.1007/s12028-025-02284-3. Epub 2025 May 21.
PubMed 40399657Lee 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.
PubMed 35676589Foster 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.
PubMed 35306827Wei 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.
PubMed 34789008Lun 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.
PubMed 33758069Selim 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.
PubMed 30898550
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Deferoxamine Mesylate in Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02175225
- Acronym / sponsor ID
- 2012P000005
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Brain hemorrhage, Cerebral hemorrhage, Bleeding in the brain, Deferoxamine, iDEF trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- 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
- Study start
- Oct 2014 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 30 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferoxamine Mesylate | Experimental | Drug: Deferoxamine MesylateDeferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days |
| Normal Saline | Placebo comparator | Drug: Placebo (for Deferoxamine Mesylate)Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferoxamine Mesylate | Drug | Deferoxamine Mesylate |
| Placebo (for Deferoxamine Mesylate) | Drug | Normal Saline |
Primary outcome
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days
Time frame: 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
Time frame: 90 days
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
Time frame: 7 days
Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization
4 secondary outcomes
Proportion of Patients With mRS Score 0-3 at 90 Days
Time frame: 90 days
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days
Time frame: 180 days
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days
Time frame: 180 days
Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23943316Yeatts 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.
- Background: PubMed 21868742Selim 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.
- Background: PubMed 19064798Selim 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.
- Background: PubMed 24187595Hatakeyama 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.
- Background: PubMed 24172580Xie 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.
- Background: PubMed 20044521Okauchi 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.
- Background: PubMed 24366522Sonni 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.
- Derived from this study: PubMed 40789806Polymeris 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 Dec;43(3):824-833. doi: 10.1007/s12028-025-02337-7. Epub 2025 Aug 11.
- Derived from this study: PubMed 40418029Polymeris AA, Lioutas VA, Foster LD, Incontri D, Heistand EC, Marchal J, Lazar A, Fischer U, Engelter ST, Seiffge DJ, Yeatts SD, Selim MH. Early neurological improvement with deferoxamine after intracerebral hemorrhage: A post hoc analysis of the i-DEF trial. Int J Stroke. 2025 Dec;20(10):1235-1245. doi: 10.1177/17474930251348088. Epub 2025 May 26.
- Derived from this study: PubMed 40399657Polymeris 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. 2026 Feb;44(1):64-71. doi: 10.1007/s12028-025-02284-3. Epub 2025 May 21.
- Derived from this study: PubMed 35676589Lee 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.
- Derived from this study: PubMed 35306827Foster 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.
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Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdy Selim, MD, PhD study chair
Beth Israel Deaconess Medical Center
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferoxamine Mesylate in people with Intracerebral Hemorrhage, run by Beth Israel Deaconess Medical Center at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175225, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.