- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216513
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
July 17, 2015 updated by: Farzaneh Sorond, Brigham and Women's Hospital
Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of spontaneous SAH
- impaired cerebral autoregulation on day 2-4 post SAH
Exclusion Criteria:
- traumatic SAH
- other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations
- pregnancy
- severe renal disease or anuria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Desferrioxamine (DFO)
DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
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DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
Other Names:
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Placebo Comparator: placebo
normal saline IV for 4 hours for 5 consecutive days
|
normal saline IV for 4 hours for 5 consecutive days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delayed cerebral ischemia (DCI)
Time Frame: 6 weeks post hemorrhage
|
DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures.
All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.
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6 weeks post hemorrhage
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome at discharge
Time Frame: patient's discharge date, which averages 3-4 weeks post hemorrhage
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Clinical outcome at discharge will be assessed using modified Rankin Scale (mRS) as a global functional status.
The modified Rankin scale evaluates global disability and handicap; scores range from 0 (no symptoms or disability) to 6 (death).
Good mRS will be defined as score of ≤ 2.
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patient's discharge date, which averages 3-4 weeks post hemorrhage
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebrovascular function (i.e., cerebral autoregulation)
Time Frame: 5 days after initiation of study drug
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Spectral analysis of the relationship between arterial pressure and blood flow velocity in the bilateral middle cerebral arteries (measured via TCD).
Autoregulation will be assessed from the phase and gain of the transfer function.
Phase shift reflects the temporal difference between cerebral flow velocity fluctuations with respect to arterial pressure fluctuations.
When the fluctuations of both flow and pressure are almost synchronous, the phase shift approaches zero, reflecting impaired cerebral autoregulation.
Transfer function gain reflects the magnitude of transmission of arterial pressure fluctuations to cerebral blood flow velocity fluctuations.
Lower gain, particularly in the low frequency (< 0.1 Hz) range, is reflective of more effective cerebral autoregulation.
Coherence reflects the degree of linear dependence between pressure and flow fluctuations.
Thus, it provides a measure of validity of the metrics (gain and phase) derived from the linear transfer function.
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5 days after initiation of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Farzaneh A Sorond, MD, PhD, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 6, 2014
First Submitted That Met QC Criteria
August 12, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Estimate)
July 21, 2015
Last Update Submitted That Met QC Criteria
July 17, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infarction
- Stroke
- Brain Infarction
- Intracranial Hemorrhages
- Brain Ischemia
- Ischemia
- Hemorrhage
- Cerebral Infarction
- Subarachnoid Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Siderophores
- Deferoxamine
Other Study ID Numbers
- 2014P001400
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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