Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02216513
• Other study ID #: 2014P001400
• Status: Terminated
• Phase: Phase 0
• First received: August 6, 2014
• Last updated: July 17, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• desferrioxamine (DFO)
DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
• placebo
normal saline IV for 4 hours for 5 consecutive days

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Dr. Jeffrey Thomas Stroke Shield Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebrovascular function (i.e., cerebral autoregulation)	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.	5 days after initiation of study drug	No
Primary	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.	6 weeks post hemorrhage	No
Secondary	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.	patient's discharge date, which averages 3-4 weeks post hemorrhage	No