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CompletedNCT02175225Updated May 30, 2019Results posted

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

A Phase 2 interventional study of Deferoxamine Mesylate and Placebo (for Deferoxamine Mesylate) in Intracerebral Hemorrhage, sponsored by Beth Israel Deaconess Medical Center. Completed at 28 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
294
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Intracerebral Hemorrhage

Keywords

  • Brain hemorrhage
  • Cerebral hemorrhage
  • Bleeding in the brain
  • Deferoxamine
  • iDEF trial
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 294 is above the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
294 participants (actual)

Study arms

  • Experimental
    Deferoxamine Mesylate

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

    Drug: Deferoxamine Mesylate

  • Placebo comparator
    Normal Saline

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

    Drug: Placebo (for Deferoxamine Mesylate)

Interventions

  • DrugDeferoxamine Mesylate
  • DrugPlacebo (for Deferoxamine Mesylate)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 90 days

  2. Number of Subjects Experiencing Serious Adverse Events

    Number of subjects experiencing Serious adverse events at any time from randomization through day 90

    Time frame: 90 days

  3. Number of Subjects With Serious Adverse Events Within 7 Days

    Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 90 days

  2. 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.

    Time frame: 180 days

  3. 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.

    Time frame: 180 days

  4. 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.

    Time frame: 90 days

Other outcomes

  1. Ordinal Distribution of Scores on mRS at Day 90

    The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined.

    Time frame: 90 days

  2. Ordinal Distribution of Scores on mRS at 180 Days

    The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined.

    Time frame: 180 days

  3. Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)

    Adverse event of special interest: anaphylaxis at any time during the study infusion

    Time frame: during the study infusion

  4. Adverse Event of Special Interest: Number of Patients With Hypotension

    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

  5. Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes

    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

  6. Adverse Event of Special Interest: Number of Patients With Respiratory Compromise

    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

  7. Number of Patients With Symptomatic Cerebral Edema

    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

07

Results

Posted May 30, 2019

Participant flow

Participant flow — Overall Study
MilestoneDeferoxamine MesylateNormal Saline
Started145149
Initiated study drug144147
90 day outcome obtained140143
180 day outcome obtained135135
Completed137138
Not completed811
Withdrew: Withdrawal by subject12
Withdrew: Lost to follow-up67
Withdrew: Study drug not administered12

Outcome measures

PrimaryProportion 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.

Time frame:
90 days
Reported as:
Count of participants · Participants
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days
ParticipantsDeferoxamine MesylateNormal Saline
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days4847
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk difference (rd): 0.006Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.
PrimaryNumber of Subjects Experiencing Serious Adverse Events

Number of subjects experiencing Serious adverse events at any time from randomization through day 90

Time frame:
90 days
Reported as:
Count of participants · Participants
Number of Subjects Experiencing Serious Adverse Events
ParticipantsDeferoxamine MesylateNormal Saline
Number of Subjects Experiencing Serious Adverse Events3949
Statistical analysis
  • Deferoxamine Mesylate · Risk ratio (rr): 0.81 · 95% CI 0.57 to 1.16
PrimaryNumber of Subjects With Serious Adverse Events Within 7 Days

Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization

Time frame:
7 days
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events Within 7 Days
ParticipantsDeferoxamine MesylateNormal Saline
Number of Subjects With Serious Adverse Events Within 7 Days2426
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk ratio (rr): 0.94 · 95% CI 0.57 to 1.56
SecondaryProportion 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.

Time frame:
90 days
Reported as:
Count of participants · Participants
Proportion of Patients With mRS Score 0-3 at 90 Days
ParticipantsDeferoxamine MesylateNormal Saline
Proportion of Patients With mRS Score 0-3 at 90 Days9182
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk difference (rd): 0.062Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference\[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.
SecondaryProportion 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.

Time frame:
180 days
Reported as:
Count of participants · Participants
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days
ParticipantsDeferoxamine MesylateNormal Saline
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days6148
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk difference (rd): 0.086Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.
SecondaryProportion 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.

Time frame:
180 days
Reported as:
Count of participants · Participants
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days
ParticipantsDeferoxamine MesylateNormal Saline
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days9792
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk difference (rd): -0.018Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.
SecondaryProportion 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.

Time frame:
90 days
Reported as:
Count of participants · Participants
Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows
ParticipantsDeferoxamine MesylateNormal Saline
Onset to treatment time <=12 hours1519
Onset to treatment time >12 hours3328
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Regression, Logistic · p = 0.83 (The p value reflects the significance of the interaction term between treatment and onset to treatment time.)
Other pre-specifiedOrdinal Distribution of Scores on mRS at Day 90

The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined.

Time frame:
90 days
Reported as:
Count of participants · Participants
Ordinal Distribution of Scores on mRS at Day 90
ParticipantsDeferoxamine MesylateNormal Saline
mRS 064
mRS 11312
mRS 22931
mRS 34335
mRS 43343
mRS 567
mRS 61011
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Odds ratio (or): 1.10 · 95% CI 0.72 to 1.67The estimation parameter is the adjusted common odds ratio.
Other pre-specifiedOrdinal Distribution of Scores on mRS at 180 Days

The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined.

Time frame:
180 days
Reported as:
Count of participants · Participants
Ordinal Distribution of Scores on mRS at 180 Days
ParticipantsDeferoxamine MesylateNormal Saline
mRS 0105
mRS 11816
mRS 23327
mRS 33644
mRS 42224
mRS 547
mRS 61212
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Odds ratio, log: 1.26 · 95% CI 0.82 to 1.93
Other pre-specifiedAdverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)

Adverse event of special interest: anaphylaxis at any time during the study infusion

Time frame:
during the study infusion
Reported as:
Count of participants · Participants
Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)
ParticipantsDeferoxamine MesylateNormal Saline
Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)30
Other pre-specifiedAdverse Event of Special Interest: Number of Patients With Hypotension

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
Reported as:
Count of participants · Participants
Adverse Event of Special Interest: Number of Patients With Hypotension
ParticipantsDeferoxamine MesylateNormal Saline
Adverse Event of Special Interest: Number of Patients With Hypotension12
Other pre-specifiedAdverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes

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
Reported as:
Count of participants · Participants
Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes
ParticipantsDeferoxamine MesylateNormal Saline
Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes34
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk ratio (rr): 0.77 · 95% CI 0.0 to 14.97Confidence interval is exact (rather than asymptotic) due to small number of events.
Other pre-specifiedAdverse Event of Special Interest: Number of Patients With Respiratory Compromise

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
Reported as:
Count of participants · Participants
Adverse Event of Special Interest: Number of Patients With Respiratory Compromise
ParticipantsDeferoxamine MesylateNormal Saline
All cause2023
Cause by acute respiratory distress syndrome21
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk ratio (rr): 0.89 · 95% CI 0.51 to 1.54Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.
Other pre-specifiedNumber of Patients With Symptomatic Cerebral Edema

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
Reported as:
Count of participants · Participants
Number of Patients With Symptomatic Cerebral Edema
ParticipantsDeferoxamine MesylateNormal Saline
Number of Patients With Symptomatic Cerebral Edema95
Statistical analysis
  • Deferoxamine Mesylate vs Normal Saline · Risk ratio (rr): 1.84 · 95% CI 0.63 to 5.35

Adverse events

Collected over All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Deferoxamine Mesylate12/144 (8.3%)39/144 (27.1%)107/144 (74.3%)
Normal Saline12/147 (8.2%)50/147 (34%)114/147 (77.6%)
Most frequent serious events
Showing 10 of 63
Most frequent serious events
EventDeferoxamine MesylateNormal Saline
Brain oedemaNervous system disorders5/1442/147
Brain herniationNervous system disorders4/1442/147
HydrocephalusNervous system disorders4/1441/147
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders4/1444/147
Pulmonary embolismRespiratory, thoracic and mediastinal disorders4/1441/147
PneumoniaInfections and infestations2/1444/147
Neurological decompensationNervous system disorders1/1444/147
Respiratory failureRespiratory, thoracic and mediastinal disorders2/1444/147
SepsisInfections and infestations3/1442/147
Deep vein thrombosisVascular disorders3/1443/147
Most frequent other events
Showing 10 of 158
Most frequent other events
EventDeferoxamine MesylateNormal Saline
Urinary tract infectionInfections and infestations18/14422/147
PyrexiaGeneral disorders17/14416/147
VomitingGastrointestinal disorders13/1446/147
AgitationPsychiatric disorders13/1448/147
ArrhythmiaCardiac disorders11/14411/147
HypokalaemiaInvestigations11/1444/147
ConstipationGastrointestinal disorders6/14410/147
Renal failure acuteRenal and urinary disorders6/1449/147
Urinary retentionRenal and urinary disorders8/1447/147
HeadacheNervous system disorders7/1448/147

Baseline characteristics

As specified in the Statistical Analysis Plan, the target population is the modified ITT population, including only subjects in whom study drug was initiated.

Age, Continuous
Age, Continuous(years)Deferoxamine MesylateNormal SalineTotal
Median59 (51 to 71)62 (54 to 70)61 (52 to 70)
Sex: Female, Male
Sex: Female, Male(Participants)Deferoxamine MesylateNormal SalineTotal
Female5656112
Male8891179
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Deferoxamine MesylateNormal SalineTotal
Hispanic or Latino212748
Not Hispanic or Latino123120243
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Deferoxamine MesylateNormal SalineTotal
American Indian or Alaska Native202
Asian251237
Native Hawaiian or Other Pacific Islander314
Black or African American313364
White81100181
More than one race101
Unknown or Not Reported112
Medical history: Hypertension
Medical history: Hypertension(Participants)Deferoxamine MesylateNormal SalineTotal
Count of participants113124237
Medical history: Diabetes mellitus
Medical history: Diabetes mellitus(Participants)Deferoxamine MesylateNormal SalineTotal
Count of participants324375
Medical history: Cardiac disease
Medical history: Cardiac disease(Participants)Deferoxamine MesylateNormal SalineTotal
Count of participants141529
Medical history: Pulmonary disease
Medical history: Pulmonary disease(Participants)Deferoxamine MesylateNormal SalineTotal
Count of participants312657

4 further baseline measures are reported on the registry.

08

Study locations

28 sites
  • 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
09

References and documents

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 23943316 ↗
  • 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. PubMed 21868742 ↗
  • 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. PubMed 19064798 ↗
  • 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. PubMed 24187595 ↗
  • 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. PubMed 24172580 ↗
  • 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. PubMed 20044521 ↗
  • 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. PubMed 24366522 ↗
  • 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. PubMed 35676589 ↗
  • 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. PubMed 35306827 ↗
  • 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. PubMed 34789008 ↗
  • 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. PubMed 33758069 ↗
  • 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. PubMed 30898550 ↗

Study documents

  • Study protocol · May 15, 2014
  • Statistical analysis plan · Jul 11, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02175225
Lead 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
Responsible party
Magdy Selim (MD, PhD, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Jun 26, 2014
Start date
Oct 2014
Primary completion
Feb 10, 2018
Completion
May 30, 2018
Results posted
May 30, 2019
Last update
May 30, 2019

Study contacts

Magdy Selim, MD, PhD
study chair · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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