Trial · NCT02175225

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

NCT02175225, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2019-05-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial. Trials, record NCT02175225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02175225

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
NCT number: NCT02175225
Status: Completed
Phases: Phase 2
Enrollment: 294 participants, actual
Lead sponsor: Beth Israel Deaconess Medical Center
Conditions: Intracerebral Hemorrhage
Interventions: Deferoxamine Mesylate, Placebo (for Deferoxamine Mesylate)
First posted: 2014-06-26
Last updated: 2019-05-30
Results first posted: 2019-05-30

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	Number of Subjects Experiencing Serious Adverse Events	90 days	Number of subjects experiencing Serious adverse events at any time from randomization through day 90
Primary	Number of Subjects With Serious Adverse Events Within 7 Days	7 days	Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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	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.
Other	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.
Other	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

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days	90 days	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.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects Experiencing Serious Adverse Events	90 days	Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Serious Adverse Events Within 7 Days	7 days	Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients With mRS Score 0-3 at 90 Days	90 days	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days	180 days	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days	180 days	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows	90 days	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)	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Ordinal Distribution of Scores on mRS at Day 90	90 days	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.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Ordinal Distribution of Scores on mRS at 180 Days	180 days	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.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)	during the study infusion	Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days	Deferoxamine Mesylate	48	Participants
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days	Normal Saline	47	Participants
Number of Subjects Experiencing Serious Adverse Events	Deferoxamine Mesylate	39	Participants
Number of Subjects Experiencing Serious Adverse Events	Normal Saline	49	Participants
Number of Subjects With Serious Adverse Events Within 7 Days	Deferoxamine Mesylate	24	Participants
Number of Subjects With Serious Adverse Events Within 7 Days	Normal Saline	26	Participants
Proportion of Patients With mRS Score 0-3 at 90 Days	Deferoxamine Mesylate	91	Participants
Proportion of Patients With mRS Score 0-3 at 90 Days	Normal Saline	82	Participants
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days	Deferoxamine Mesylate	61	Participants
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days	Normal Saline	48	Participants

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Deferoxamine Mesylate	145
Overall Study	STARTED	Normal Saline	149
Overall Study	Initiated Study Drug	Deferoxamine Mesylate	144
Overall Study	Initiated Study Drug	Normal Saline	147
Overall Study	90 Day Outcome Obtained	Deferoxamine Mesylate	140
Overall Study	90 Day Outcome Obtained	Normal Saline	143
Overall Study	180 Day Outcome Obtained	Deferoxamine Mesylate	135
Overall Study	180 Day Outcome Obtained	Normal Saline	135
Overall Study	COMPLETED	Deferoxamine Mesylate	137
Overall Study	COMPLETED	Normal Saline	138

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events442

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arrhythmia	Cardiac disorders	Deferoxamine Mesylate	11	144	12
other	Arrhythmia	Cardiac disorders	Normal Saline	11	147	13
other	Myocardial infarction	Cardiac disorders	Deferoxamine Mesylate	0	144	0
other	Myocardial infarction	Cardiac disorders	Normal Saline	1	147	1
other	Myocardial ischaemia	Cardiac disorders	Deferoxamine Mesylate	0	144	0
other	Myocardial ischaemia	Cardiac disorders	Normal Saline	1	147	1
other	Ear pain	Ear and labyrinth disorders	Deferoxamine Mesylate	1	144	1
other	Ear pain	Ear and labyrinth disorders	Normal Saline	0	147	0
other	Hearing impaired	Ear and labyrinth disorders	Deferoxamine Mesylate	1	144	1
other	Hearing impaired	Ear and labyrinth disorders	Normal Saline	1	147	1

1 to 10 of 442Source ClinicalTrials.gov

See all 442 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deferoxamine Mesylate	12	144
Total, all-cause mortality	Normal Saline	12	147
Total, other adverse events	Deferoxamine Mesylate	107	144
Total, other adverse events	Normal Saline	114	147
Total, serious adverse events	Deferoxamine Mesylate	39	144
Total, serious adverse events	Normal Saline	50	147

Source ClinicalTrials.gov

Papers15

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19064798	BACKGROUND	PubMed
20044521	BACKGROUND	PubMed
21868742	BACKGROUND	PubMed
23943316	BACKGROUND	PubMed
24172580	BACKGROUND	PubMed
24187595	BACKGROUND	PubMed
24366522	BACKGROUND	PubMed
30898550	DERIVED	PubMed
33758069	DERIVED	PubMed
34789008	DERIVED	PubMed

1 to 10 of 15

See all 15 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01NS074425	Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage (i-DEF)	SELIM, MAGDY H	BETH ISRAEL DEACONESS MEDICAL CENTER	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2012 to 2016

Source NIH RePORTER

Trial comparisons12

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Deferoxamine Mesylate vs Normal Saline: Number of Subjects With Serious Adverse Events Within 7 Days	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Number of Patients With Symptomatic Cerebral Edema	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Number of Subjects Experiencing Serious Adverse Events	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Proportion of Patients With mRS Score 0-3 at 90 Days	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)	Trial comparisons
Deferoxamine Mesylate vs Normal Saline: Adverse Event of Special Interest: Number of Patients With Hypotension	Trial comparisons

1 to 10 of 12

See all 12 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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