Safety and Efficacy of NBO in Acute Intracerebral Hemorrhage

Capital Medical University

Status: Unknown

Conditions: Cerebral Hemorrhage; Normobaric Oxygen

Treatments: Other: Normobaric Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04144868

NBO-ICH

Details and patient eligibility

About

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 supply,which 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 hemorrhage.The 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 NSSs,decreased 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 hemorrhage.NBO has the advantages of simple operation, non-invasiveness and early application, which makes it have great application prospects in the treatment of ICH.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient Age ≥ 18 and ≤ 80 years;
2. The diagnosis of ICH is confirmed by brain CT scan;
3. NIHSS score ≥ 6 and GCS > 8 upon presentation;
4. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
5. Signed and dated informed consent is obtained.

Exclusion criteria

1. Known history of severe chronic obstructive pulmonary disease (Forced Expiratory Vital Capacity less than 1.0L or oxygen dependent).
2. New York Heart Association Class III heart failure.
3. Patient will undergo surgical evacuation of ICH .
4. Inability to undergo neuroimaging with MRI .
5. GCS <8
6. Baseline mRS ≥ 2
7. Intraparenchymal hematoma secondary to rupture of cerebral aneurysm or bleeding of arteriovenous (A-V) malformation or cerebral tumors
8. Any condition which, in the judgment of the investigator, might increase the risk to the patient.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Experimental: NBO group

Experimental group

Description:

For eligible patients into the group of cerebral hemorrhage,Low-flow oxygen is delivered through the facemask at a rate of 8 L/min, once a hour, every 4 hours. Regular treatment is based on associated guidelines for ICH .

Treatment:

Other: Normobaric Oxygen

Control group

No Intervention group

Description:

Low-flow oxygen is delivered through the facemask at a rate of 2 L/min, once a hour, every 4 hours. Regular treatment is based on associated guidelines for ICH .