Trial · NCT01662895
High-Dose Deferoxamine in Intracerebral Hemorrhage
NCT01662895, Phase 2, Terminated, Beth Israel Deaconess Medical Center; results first posted 2019-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-Dose Deferoxamine in Intracerebral Hemorrhage. Trials, record NCT01662895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01662895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Dose Deferoxamine in Intracerebral Hemorrhage
- NCT number
- NCT01662895
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Deferoxamine, Normal saline
- First posted
- 2012-08-13
- Last updated
- 2019-06-12
- Results first posted
- 2019-05-30
- Limitations and caveats
- The study was terminated prematurely, and only 42 subjects were enrolled. As a result, any formal evaluation of these outcomes would be under-powered. Only descriptive statistics are provided.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Modified Rankin Scale (mRS) Score 0-2 | 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 minimum mRS score is 0 (i.e. no disability). The maximum score is 6 (i.e. dead). |
| Secondary | Number of Subjects With mRS Score 0-3 | 90 days | The proportion of DFO- and placebo-treated subjects with mRS 0-3 vs. 4-6 at 90 days |
| Other | Number of Subjects With Allergic/Anaphylactic Reaction | within 7 days or discharge | |
| Other | Number of Patients With Hypotension | within 7 days or discharge | |
| Other | Number of Patients With New Visual or Auditory Changes | within 7 days or discharge | |
| Other | Number of Patients With Serious Adverse Events | 90 days | |
| Other | Number of Patients Who Died During the 90-day Study Period | 90 days | Mortality at any time from randomization through day-90 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Modified Rankin Scale (mRS) Score 0-2 | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects With mRS Score 0-3 | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Subjects With Allergic/Anaphylactic Reaction | within 7 days or discharge | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Patients With Hypotension | within 7 days or discharge | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Patients With New Visual or Auditory Changes | within 7 days or discharge | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Patients With Serious Adverse Events | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Patients Who Died During the 90-day Study Period | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| POST_HOC | Number of Subjects With Acute Respiratory Distress Syndrome | 90 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Modified Rankin Scale (mRS) Score 0-2 | Deferoxamine | 6 | Participants | ||
| Number of Subjects With Modified Rankin Scale (mRS) Score 0-2 | Normal Saline | 10 | Participants | ||
| Number of Subjects With mRS Score 0-3 | Deferoxamine | 12 | Participants | ||
| Number of Subjects With mRS Score 0-3 | Normal Saline | 14 | Participants | ||
| Number of Subjects With Allergic/Anaphylactic Reaction | Deferoxamine | 0 | Participants | ||
| Number of Subjects With Allergic/Anaphylactic Reaction | Normal Saline | 0 | Participants | ||
| Number of Patients With Hypotension | Deferoxamine | 1 | Participants | ||
| Number of Patients With Hypotension | Normal Saline | 1 | Participants | ||
| Number of Patients With New Visual or Auditory Changes | Deferoxamine | 0 | Participants | ||
| Number of Patients With New Visual or Auditory Changes | Normal Saline | 1 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Deferoxamine | 21 | |
| Overall Study | STARTED | Normal Saline | 21 | |
| Overall Study | Initiated Study Drug | Deferoxamine | 21 | |
| Overall Study | Initiated Study Drug | Normal Saline | 21 | |
| Overall Study | COMPLETED | Deferoxamine | 21 | |
| Overall Study | COMPLETED | Normal Saline | 20 | |
| Overall Study | NOT COMPLETED | Deferoxamine | 0 | |
| Overall Study | NOT COMPLETED | Normal Saline | 1 |
Source ClinicalTrials.gov
Adverse events250
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 | Anaemia | Blood and lymphatic system disorders | Deferoxamine | 1 | 21 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Normal Saline | 3 | 21 | 3 |
| other | Coagulopathy | Blood and lymphatic system disorders | Deferoxamine | 1 | 21 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | Normal Saline | 1 | 21 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Deferoxamine | 3 | 21 | 3 |
| other | Leukocytosis | Blood and lymphatic system disorders | Normal Saline | 1 | 21 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Deferoxamine | 1 | 21 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Normal Saline | 0 | 21 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Deferoxamine | 1 | 21 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Normal Saline | 0 | 21 | 0 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Deferoxamine | 3 | 21 |
| Total, all-cause mortality | Normal Saline | 0 | 21 |
| Total, other adverse events | Deferoxamine | 17 | 21 |
| Total, other adverse events | Normal Saline | 18 | 21 |
| Total, serious adverse events | Deferoxamine | 9 | 21 |
| Total, serious adverse events | Normal Saline | 6 | 21 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Deferoxamine vs Normal Saline: Number of Subjects With Allergic/Anaphylactic Reaction | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Patients Who Died During the 90-day Study Period | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Subjects With Modified Rankin Scale (mRS) Score 0-2 | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Patients With Hypotension | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Patients With Serious Adverse Events | Trial comparisons |
| Deferoxamine vs Normal Saline: deaths from any cause | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Subjects With mRS Score 0-3 | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Subjects With Acute Respiratory Distress Syndrome | Trial comparisons |
| Deferoxamine vs Normal Saline: Number of Patients With New Visual or Auditory Changes | Trial comparisons |
| Deferoxamine vs Normal Saline: serious adverse events | 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.
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.
GET https://conductscience.org/api/trials/v1/NCT01662895
GET https://conductscience.org/api/trials/v1/NCT01662895/events?page=2