Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
desferrioxamine (DFO)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring subarachnoid hemorrhage, SAH, DFO, cerebral autoregulation, delayed cerebral ischemia
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Desferrioxamine (DFO)
placebo
Arm Description
DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
normal saline IV for 4 hours for 5 consecutive days
Outcomes
Primary Outcome Measures
delayed cerebral ischemia (DCI)
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.
Secondary Outcome Measures
Clinical outcome at discharge
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.
Full Information
NCT ID
NCT02216513
First Posted
August 6, 2014
Last Updated
July 17, 2015
Sponsor
Brigham and Women's Hospital
Collaborators
Dr. Jeffrey Thomas Stroke Shield Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02216513
Brief Title
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Official Title
Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Principle Investigator is moving to another institution and plans to restart this proctocol in the new location.
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Dr. Jeffrey Thomas Stroke Shield Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
subarachnoid hemorrhage, SAH, DFO, cerebral autoregulation, delayed cerebral ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desferrioxamine (DFO)
Arm Type
Active Comparator
Arm Description
DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
normal saline IV for 4 hours for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
desferrioxamine (DFO)
Other Intervention Name(s)
deferoxamine, desferal, DFO, deferoxamine mesylate
Intervention Description
DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline NS
Intervention Description
normal saline IV for 4 hours for 5 consecutive days
Primary Outcome Measure Information:
Title
delayed cerebral ischemia (DCI)
Description
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.
Time Frame
6 weeks post hemorrhage
Secondary Outcome Measure Information:
Title
Clinical outcome at discharge
Description
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.
Time Frame
patient's discharge date, which averages 3-4 weeks post hemorrhage
Other Pre-specified Outcome Measures:
Title
Cerebrovascular function (i.e., cerebral autoregulation)
Description
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.
Time Frame
5 days after initiation of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzaneh A Sorond, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33236783
Citation
Van der Loo LE, Aquarius R, Teernstra O, Klijn K, Menovsky T, van Dijk JMC, Bartels R, Boogaarts HD. Iron chelators for acute stroke. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD009280. doi: 10.1002/14651858.CD009280.pub3.
Results Reference
derived
Learn more about this trial
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
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