Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04144868
Status:
UNKNOWN
Last Update Posted:
2019-10-30
First Post:
2019-10-22
Brief Title:
Safety and Efficacy of NBO in Acute Intracerebral Hemorrhage
Sponsor:
Capital Medical University
Organization:
Capital Medical University
Study Overview
Official Title:
Safety and Efficacy of NBO in Acute Intracerebral Hemorrhage
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intracerebral hemorrhage ICH is one of the most devastating nontraumatic cerebral vascular diseases Its exacerbation is often related to a mass effect because of hematoma formation and edema in the perihematoma which plays a key role in disease deterioration Perihematoma edema is an important contributor to brain injuries secondary to ICH and one of the risk factors that leads to disease deterioration and high mortality Brain edema following ICH was believed to be induced by the breakdown of the blood-brain barrier and ischemia and hypoxia of the perihematoma
Normobaric oxygen NBO therapy is a treatment that delivers high-flow oxygen at normobaric pressure through a facemask to supplement the oxygen supplywhich maintain the oxygen concentration of typically 40-100 can increase the arterial oxygen content and alleviate tissue hypoxia NBO therapy has been shown to provide neuroprotection against ischemic stroke in an experimental study and a clinical trial To the best of our knowledge the potential of NBO therapy for neuroprotection against human hemorrhagic stroke has not been investigated
There are two studies about NBO interventions in the rat model of intracerebral hemorrhageThe one showed NBO did not worsen hemorrhage severity or brain edema There were no significant differences in hemorrhagic blood volumes or brain water content NBO did not affect any of the neurological outcome tests in the primary or secondary studies Another one showed NBO groups improved NSSsdecreased contents of brain water HIF-1α and VEGF and fewer apoptotic cells in the perihematoma at 72 h after ICH compared with the ICH control group These results suggest that NBO therapy with oxygen delivered at 90 conferred best neuroprotection to ICH rats potentially through amelioration of brain edema by suppressing HIF-1α and VEGF expression in the perihematoma
But there is no clinical study on the safety and efficacy of NBO in patients with intracerebral hemorrhageNBO has the advantages of simple operation non-invasiveness and early application which makes it have great application prospects in the treatment of ICH
Normobaric oxygen NBO therapy is a treatment that delivers high-flow oxygen at normobaric pressure through a facemask to supplement the oxygen supplywhich maintain the oxygen concentration of typically 40-100 can increase the arterial oxygen content and alleviate tissue hypoxia NBO therapy has been shown to provide neuroprotection against ischemic stroke in an experimental study and a clinical trial To the best of our knowledge the potential of NBO therapy for neuroprotection against human hemorrhagic stroke has not been investigated
There are two studies about NBO interventions in the rat model of intracerebral hemorrhageThe one showed NBO did not worsen hemorrhage severity or brain edema There were no significant differences in hemorrhagic blood volumes or brain water content NBO did not affect any of the neurological outcome tests in the primary or secondary studies Another one showed NBO groups improved NSSsdecreased contents of brain water HIF-1α and VEGF and fewer apoptotic cells in the perihematoma at 72 h after ICH compared with the ICH control group These results suggest that NBO therapy with oxygen delivered at 90 conferred best neuroprotection to ICH rats potentially through amelioration of brain edema by suppressing HIF-1α and VEGF expression in the perihematoma
But there is no clinical study on the safety and efficacy of NBO in patients with intracerebral hemorrhageNBO has the advantages of simple operation non-invasiveness and early application which makes it have great application prospects in the treatment of ICH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None