Intracerebral Hemorrhage
Conditions
Keywords
Brain hemorrhage, Cerebral hemorrhage, Bleeding in the brain, Deferoxamine, iDEF trial
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.
Interventions
DRUGPlacebo (for Deferoxamine Mesylate)
Sponsors
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
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | 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 With Serious Adverse Events Within 7 Days | 7 days | Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization |
| Number of Subjects Experiencing Serious Adverse Events | 90 days | Number of subjects experiencing Serious adverse events at any time from randomization through day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With mRS Score 0-3 at 90 Days | 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 | 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 | 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 | 90 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event of Special Interest: Number of Patients With Hypotension | during the study infusion | Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes |
| Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug) | during the study infusion | Adverse event of special interest: anaphylaxis at any time during the study infusion |
| Ordinal Distribution of Scores on mRS at 180 Days | 180 days | The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined. |
| Ordinal Distribution of Scores on mRS at Day 90 | 90 days | The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined. |
| Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes | after initiation of study infusion | Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion |
| Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | 7 days | Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge \[whichever was earlier\] |
| Number of Patients With Symptomatic Cerebral Edema | 7 days | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deferoxamine Mesylate Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days
Deferoxamine Mesylate | 144 |
| Normal Saline Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days
Placebo (for Deferoxamine Mesylate) | 147 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 |
| Overall Study | Study drug not administered | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Deferoxamine Mesylate | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 59 years | 62 years | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 27 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 120 Participants | 243 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Intraventricular hemorrhage present | 47 Participants | 62 Participants | 109 Participants |
| Location of intracerebral hemorrhage Deep (non-thalamic) | 73 Participants | 53 Participants | 126 Participants |
| Location of intracerebral hemorrhage Deep (thalamic) | 45 Participants | 61 Participants | 106 Participants |
| Location of intracerebral hemorrhage Lobar | 26 Participants | 33 Participants | 59 Participants |
| Medical history: Cardiac disease | 14 Participants | 15 Participants | 29 Participants |
| Medical history: Diabetes mellitus | 32 Participants | 43 Participants | 75 Participants |
| Medical history: Hypertension | 113 Participants | 124 Participants | 237 Participants |
| Medical history: Previous intracerebral hemorrhage | 7 Participants | 3 Participants | 10 Participants |
| Medical history: Previous ischemic stroke or transient ischemic attack | 10 Participants | 16 Participants | 26 Participants |
| Medical history: Pulmonary disease | 31 Participants | 26 Participants | 57 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 12 Participants | 37 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 33 Participants | 64 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 81 Participants | 100 Participants | 181 Participants |
| Sex: Female, Male Female | 56 Participants | 56 Participants | 112 Participants |
| Sex: Female, Male Male | 88 Participants | 91 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 144 | 12 / 147 |
| other Total, other adverse events | 107 / 144 | 114 / 147 |
| serious Total, serious adverse events | 39 / 144 | 50 / 147 |
Outcome results
Primary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Number of Subjects Experiencing Serious Adverse Events | 39 Participants |
| Normal Saline | Number of Subjects Experiencing Serious Adverse Events | 49 Participants |
95% CI: [0.57, 1.16]
Primary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Number of Subjects With Serious Adverse Events Within 7 Days | 24 Participants |
| Normal Saline | Number of Subjects With Serious Adverse Events Within 7 Days | 26 Participants |
95% CI: [0.57, 1.56]
Primary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | 48 Participants |
| Normal Saline | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | 47 Participants |
Secondary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days | 61 Participants |
| Normal Saline | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days | 48 Participants |
Secondary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days | 97 Participants |
| Normal Saline | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days | 92 Participants |
Secondary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Proportion of Patients With mRS Score 0-3 at 90 Days | 91 Participants |
| Normal Saline | Proportion of Patients With mRS Score 0-3 at 90 Days | 82 Participants |
Secondary
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. Subgroup analysis by Onset to treatment time window (\<=12 hours vs \>12 hours)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deferoxamine Mesylate | Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | Onset to treatment time <=12 hours | 15 Participants |
| Deferoxamine Mesylate | Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | Onset to treatment time >12 hours | 33 Participants |
| Normal Saline | Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | Onset to treatment time <=12 hours | 19 Participants |
| Normal Saline | Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | Onset to treatment time >12 hours | 28 Participants |
p-value: 0.83Regression, Logistic
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug) | 3 Participants |
| Normal Saline | Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug) | 0 Participants |
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Adverse Event of Special Interest: Number of Patients With Hypotension | 1 Participants |
| Normal Saline | Adverse Event of Special Interest: Number of Patients With Hypotension | 2 Participants |
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes | 3 Participants |
| Normal Saline | Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes | 4 Participants |
95% CI: [0, 14.97]
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deferoxamine Mesylate | Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | All cause | 20 Participants |
| Deferoxamine Mesylate | Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | Cause by acute respiratory distress syndrome | 2 Participants |
| Normal Saline | Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | All cause | 23 Participants |
| Normal Saline | Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | Cause by acute respiratory distress syndrome | 1 Participants |
95% CI: [0.51, 1.54]
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deferoxamine Mesylate | Number of Patients With Symptomatic Cerebral Edema | 9 Participants |
| Normal Saline | Number of Patients With Symptomatic Cerebral Edema | 5 Participants |
95% CI: [0.63, 5.35]
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 2 | 33 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 4 | 22 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 1 | 18 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 5 | 4 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 3 | 36 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 6 | 12 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at 180 Days | mRS 0 | 10 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 6 | 12 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 0 | 5 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 1 | 16 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 2 | 27 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 3 | 44 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 4 | 24 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at 180 Days | mRS 5 | 7 Participants |
95% CI: [0.82, 1.93]
Other Pre-specified
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
Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 2 | 29 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 4 | 33 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 1 | 13 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 5 | 6 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 3 | 43 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 6 | 10 Participants |
| Deferoxamine Mesylate | Ordinal Distribution of Scores on mRS at Day 90 | mRS 0 | 6 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 6 | 11 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 0 | 4 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 1 | 12 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 2 | 31 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 3 | 35 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 4 | 43 Participants |
| Normal Saline | Ordinal Distribution of Scores on mRS at Day 90 | mRS 5 | 7 Participants |
95% CI: [0.72, 1.67]