Abstract
BackgroundAll of the existing medication and surgical therapies currently cannot completely inhibit intracerebral hemorrhage (ICH)-mediated brain damage, resulting in disability in different degrees in the involved patients. Normobaric oxygenation (NBO) was reported attenuating ischemic brain injury. Herein, we aimed to explore the safety and efficacy of NBO on rescuing the damaged brain tissues secondary to acute ICH, especially those in the perihematoma area being threatened by ischemia and hypoxia.MethodsA total of 150 patients confirmed as acute spontaneous ICH by computed tomography (CT) within 6 h after symptoms onset, will enroll in this study after signing the informed consent, and enter into the NBO group or control group randomly according to a random number. In the NBO group, patients will inhale high-flow oxygen (8 L/min, 1 h each time for 6 cycles daily) and intake low-flow oxygen (2 L/min) in intermittent periods by mask for a total of 7 days. While in the control group, patients will breathe in only low-flow oxygen (2 L/min) by mask for 7 consecutive days. Computed tomography and perfusion (CT/CTP) will be used to evaluate cerebral perfusion status and brain edema. CT and CTP maps in the two groups at baseline and day 7 and 14 after NBO or low-flow oxygen control will be compared. The primary endpoint is mRS at both Day14 post-ICH and the end of the 3rd month follow-up. The secondary endpoints include NIHSS and plasma biomarkers at baseline and Day-1, 7, and 14 after treatment, as well as the NIHSS at the end of the 3rd month post-ICH and the incidence of bleeding recurrence and the mortalities within 3 months post-ICH.DiscussionThis study will provide preliminary clinical evidence about the safety and efficacy of NBO on correcting acute ICH and explore some mechanisms accordingly, to offer reference for larger clinical trials in the future.Trial registrationClinicalTrials.gov NCT04144868. Retrospectively registered on October 29, 2019.
Highlights
All of the existing medication and surgical therapies currently cannot completely inhibit intracerebral hemorrhage (ICH)-mediated brain damage, resulting in disability in different degrees in the involved patients
Brain injury in the perihematoma area was considered as one of the major causes related to poor outcomes of ICH patients [22]
Research revealed that ICHmediated perihematoma brain injury included cerebral edema, ischemia, and inflammation [22,23,24,25,26]
Summary
All of the existing medication and surgical therapies currently cannot completely inhibit intracerebral hemorrhage (ICH)-mediated brain damage, resulting in disability in different degrees in the involved patients. The incidence of spontaneous intracranial hemorrhage (ICH) was reported as 10–30/100,000 worldwide, which only accounted for 10–15% in all stroke subtypes, both the burden of disability and the ratio of mortality were very higher than other stroke subtypes, even though they underwent medication and surgical treatment, resulting in poor clinical outcomes [1]. Brain edema in the perihematoma area was reported to contribute a lot on ICHmediated brain damage and closely associated with poor clinical outcomes, such as deterioration or even death [2,3,4]. No proper method is accepted on this aspect up to now
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