Subarachnoid Hemorrhage Clinical Trial
Official title:
Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Dr. Jeffrey Thomas Stroke Shield Foundation |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Recruiting |
NCT04189471 -
Recovery After Cerebral Hemorrhage
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05131295 -
Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
|
Phase 3 | |
Recruiting |
NCT02962349 -
TRansfusion Strategies in Acute Brain INjured Patients
|
N/A | |
Completed |
NCT02872857 -
Subarachnoid Hemorrhage Recovery And Galantamine
|
Phase 1/Phase 2 | |
Completed |
NCT03164434 -
Influence of Drainage on EVD ICP-signal
|
||
Not yet recruiting |
NCT00905931 -
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
|
Phase 2 | |
Completed |
NCT01077206 -
High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage
|
Phase 2/Phase 3 | |
Completed |
NCT02389634 -
Identification of Novel Molecular Markers for Vasospasm
|
||
Completed |
NCT01261091 -
Early Tracheostomy in Ventilated Stroke Patients
|
N/A | |
Completed |
NCT00962546 -
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT00507104 -
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
|
||
Completed |
NCT00071565 -
Familial Intracranial Aneurysm Study II
|
N/A | |
Recruiting |
NCT05113381 -
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH
|
N/A | |
Completed |
NCT04052646 -
Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
|
||
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Recruiting |
NCT06033378 -
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.
|
N/A | |
Completed |
NCT04308577 -
Diet Induced Ketosis for Brain Injury - A Feasibility Study
|
N/A | |
Recruiting |
NCT06103201 -
Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
|
Phase 1 |