Safety and Efficacy of NBO in Acute Intracerebral Hemorrhage

October 29, 2019 updated by: Ran Meng, Capital Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100053
        • Xuanwu Hospital, Captial Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: NBO group

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 .
Other: Normobaric Oxygen
No Intervention: Control group

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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of death or major disability
Time Frame: 90 days after the onset
90 days after the onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the midline shift from the initial to follow-up CT/MRI scans
Time Frame: Day0, Day1,Day3,Day7,Day14
Day0, Day1,Day3,Day7,Day14
The change in the volume of ICH from the initial to follow-up CT/MRI scans
Time Frame: Day0, Day1,Day3,Day7,Day14
Day0, Day1,Day3,Day7,Day14
The change of cerebral blood flow in perihematomal lesions follow-up CTP scans
Time Frame: Day0, Day1,Day7
Day0, Day1,Day7
The evaluation of neurological impairment caused by a stroke
Time Frame: Day0, Day1,Day3,Day7,Day90
National Institute of Health stroke scale(NIHSS),The score ranges from 0 to 42. The higher the score, the more severe the nerve damage.
Day0, Day1,Day3,Day7,Day90
Neurological function outcome
Time Frame: Day90
The modified Rankin scale is used to measure the recovery of neurological function in patients after stroke. The score range is from 0 to 5. The higher the score, the worse the neurological function is restored. We need to calculate the proportion of the modified Rankin scale 0-2.
Day90
The evaluation of serum biomarkers
Time Frame: Day0, Day1,Day3,Day7,Day14
We used ELISA kits to detect the lebvels of neuron - specific enolase (NSE) ， matrix metalloprotease 9 (MMP-9)， reactive oxygen species (ROS) and hypoxia-inducing factor 1a (HIF-1a) in blood. The results were measured in ng/ml.
Day0, Day1,Day3,Day7,Day14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2019

Primary Completion (Anticipated)

August 8, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBO-ICH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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