Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 198 for:    Hemorrhage AND SAH

Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02216513
Recruitment Status : Terminated (Principle Investigator is moving to another institution and plans to restart this proctocol in the new location.)
First Posted : August 15, 2014
Last Update Posted : July 21, 2015
Sponsor:
Collaborator:
Dr. Jeffrey Thomas Stroke Shield Foundation
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE August 6, 2014
First Posted Date  ICMJE August 15, 2014
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02216513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
Clinical outcome at discharge [ Time Frame: patient's discharge date, which averages 3-4 weeks post hemorrhage ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 12, 2014)
Cerebrovascular function (i.e., cerebral autoregulation) [ Time Frame: 5 days after initiation of study drug ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Official Title  ICMJE Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Subarachnoid Hemorrhage
Intervention  ICMJE
  • Drug: desferrioxamine (DFO)
    DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
    Other Name: deferoxamine, desferal, DFO, deferoxamine mesylate
  • Drug: placebo
    normal saline IV for 4 hours for 5 consecutive days
    Other Name: normal saline NS
Study Arms  ICMJE
  • Active Comparator: Desferrioxamine (DFO)
    DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
    Intervention: Drug: desferrioxamine (DFO)
  • Placebo Comparator: placebo
    normal saline IV for 4 hours for 5 consecutive days
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 17, 2015)
2
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2014)
24
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02216513
Other Study ID Numbers  ICMJE 2014P001400
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farzaneh Sorond, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Dr. Jeffrey Thomas Stroke Shield Foundation
Investigators  ICMJE
Principal Investigator: Farzaneh A Sorond, MD, PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP