Normobaric Hyperoxia for Intracerebral Hemorrhage

April 13, 2025 updated by: Ran Meng, Capital Medical University

Normobaric Hyperoxia for Intracerebral Hemorrhage A Randomized Clinical Trial

Perihematoma edema (PHE), as the major injury for intracranial hemorrhage (ICH) involves more than the initial tissue damage induced directly by the hematoma. How to improve hypoxia in perihematoma seems to be a promising therapeutic candidate paradigm for ICH due to its pivotal role in the pathogenesis of perihematomas. Normobaric hyperoxia (NBO), supplied by a face mask (such as oxygen storage face mask) with atmosphere pressure (1ATA = 101.325 kPa, 100% O2), has been considered a safe, convenient, and promising therapy for correcting various diseases and thus garnered great attention in recent years. The previous study identified that early NBO could attenuate blood-brain barrier damage, rescue penumbra and finally improve the prognosis of ischemic stroke in patients with delayed rt-PA treatment. Therefore, given the profound effectiveness in the ischemic penumbra, we hypothesized that NBO might yield additional benefits for the ischemic-hypoxic tissues surrounding the hematoma in patients with ICH. Although many clinical trials have shown the effectiveness and safety of NBO in treating ischemic stroke, there is currently a lack of trials focusing on using NBO to treat ICH. Accordingly, we conducted a proof-of-concept, single-center, randomized controlled trial to evaluate the safety and efficacy of NBO in treating ICH patients so as to explore an innovative adjuvant therapy for ICH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intracerebral hemorrhage (ICH) is an intractable and life-threatening stroke subtype that imposes a significant impact on people's well-being and quality of life. ICH-induced mechanical compression to the surrounding brain tissue is a major injury that increases intracranial pressure (ICP). High ICP can decrease cerebral blood flow (CBF) and influence cerebral metabolism in perihematoma and even the whole brain. Decreased aerobic metabolism and perfusion in perihematomal injury can exacerbate edema and enlarge hematoma. Moreover, secondary injury in the perihematoma, such as ischemia, oxidative stress, inflammatory response, and protease release, involves more than the initial tissue damage induced directly by the hematoma. Theoretically, low CBF and abnormal metabolism in ICH patients expose the brain tissue to the ischemic-hypoxic condition, which is similar to that in the ischemic penumbra in stroke. Therefore, the key to treating ICH is to find an approach that can rescue the perihematoma. Improving hypoxia in perihematoma seems to be a promising therapeutic candidate paradigm for ICH due to its pivotal role in the pathogenesis of perihematomas.

Normobaric hyperoxia (NBO), supplied by a face mask (such as oxygen storage face mask) with atmosphere pressure (1ATA = 101.325 kPa, 100% O2), has been considered a safe, convenient, and promising therapy for correcting various diseases and thus garnered great attention in recent years. The effectiveness of NBO on ischemic stroke (IS) has been fully identified. A plethora of studies show that NBO is capable of increasing the partial pressure of oxygen (PO2), elevating the blood flow and volume, protecting the blood-brain barrier (BBB), improving oxidative metabolism, reducing free radical damage, and even relieving inflammatory response in the penumbra. Rapid amelioration of hypoxia in brain tissue can restore brain dysfunction and improve clinical prognoses. Likewise, NBO is also regarded as a promising method for treating ICH. An animal study found that NBO for a period of 6 h per day for 3 consecutive days imposed a remarkable neuroprotective effect in rat ICH, improved neurological function, reduced brain edema, downregulated HIF-1α and VEGF expression and showed a reduction in apoptotic cells in the perihematoma. Although many clinical trials have shown the effectiveness and safety of NBO in treating ischemic stroke, there is currently a lack of trials focusing on using NBO to treat ICH. Accordingly, we conducted a proof-of-concept, single-center, randomized controlled trial to evaluate the safety and efficacy of NBO in treating ICH patients so as to explore an innovative adjuvant therapy for ICH.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

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

Description

Inclusion criteria:

  1. supratentorial hematomas confirmed by admitted cranial computed tomography (CT), with the volume ranging from 10 to 30 mL;
  2. age 18-80 years;
  3. National Institute of Health Stroke Scale (NIHSS) ≥ 6 and Glasgow Coma Scale (GCS) > 8 at admission;
  4. onset-to-enrollment time ≤ 24 h;
  5. signed informed consent.

Exclusion criteria:

  1. a history of ICH, ischemic attack, brain tumor, brain trauma, and other intracranial injury or disorders;
  2. pre-stroke modified ranking scales (mRS) ≥ 1;
  3. life-threatening condition;
  4. pre-stroke complicated with austere diseases such as cancer, heart failure, and respiratory failures;
  5. severe liver and kidney disorders;
  6. a history of respiratory diseases;
  7. poor compliance;
  8. participation in other clinical trials within the previous three months.

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: NBO group
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Device: Oxygen storage face masks and nasal catheter
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Placebo Comparator: Control group
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.
Device: Nasal catheter
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With mRS 0-3
Time Frame: 90 days
modified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS Scores
Time Frame: 3 days
The NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
3 days
NIHSS Scores
Time Frame: 7 days
The NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
7 days
NIHSS Scores
Time Frame: 14 days
The NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
14 days
Glasgow Coma Scale
Time Frame: 3 days
Glasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
3 days
Glasgow Coma Scale
Time Frame: 7 days
Glasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
7 days
Glasgow Coma Scale
Time Frame: 14 days
Glasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
14 days
Barthel Index
Time Frame: 90 days
Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
90 days
mRS Distribution
Time Frame: 90 days
modified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
90 days
Hematoma Volume
Time Frame: 3 days
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
3 days
Hematoma Volume
Time Frame: 7 days
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
7 days
Hematoma Volume
Time Frame: 14 days
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
14 days
Absolute Perihematomal Edema Volume
Time Frame: 3 days
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
3 days
Absolute Perihematomal Edema Volume
Time Frame: 7 days
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
7 days
Absolute Perihematomal Edema Volume
Time Frame: 14 days
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
14 days
Relative Perihematomal Edema Volume
Time Frame: 3 days
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
3 days
Relative Perihematomal Edema Volume
Time Frame: 7 days
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
7 days
Relative Perihematomal Edema Volume
Time Frame: 14 days
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
14 days

Collaborators and Investigators

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

Sponsor

Capital Medical University

Collaborators

Jiujiang University Affiliated Hospital

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 (Actual)

January 15, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 31, 2022

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)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOTCH

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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