Phase 2
N=96
Normobaric Hyperoxia for Intracerebral Hemorrhage
Normobaric Hyperoxia · Intracerebral Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT04144868 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Percentage of Patients With mRS 0-3 — 39; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxygen storage face masks and nasal catheter (Device); Nasal catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Capital Medical University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With mRS 0-3 |
39; 27 | — |
| SECONDARY NIHSS Scores |
5; 7 | — |
| SECONDARY NIHSS Scores |
5; 7 | — |
| SECONDARY NIHSS Scores |
5; 7 | — |
| SECONDARY Glasgow Coma Scale |
15; 15 | — |
| SECONDARY Glasgow Coma Scale |
15; 15 | — |
| SECONDARY Glasgow Coma Scale |
15; 15 | — |
| SECONDARY Barthel Index |
80; 47.5 | — |
| SECONDARY mRS Distribution |
2; 3 | — |
| SECONDARY Hematoma Volume |
5.85; 6.37 | — |
| SECONDARY Hematoma Volume |
5.85; 6.37 | — |
| SECONDARY Hematoma Volume |
5.85; 6.37 | — |
| SECONDARY Absolute Perihematomal Edema Volume |
16.17; 20.93 | — |
| SECONDARY Absolute Perihematomal Edema Volume |
16.17; 20.93 | — |
| SECONDARY Absolute Perihematomal Edema Volume |
16.17; 20.93 | — |
| SECONDARY Relative Perihematomal Edema Volume |
0.96; 1.23 | — |
| SECONDARY Relative Perihematomal Edema Volume |
0.96; 1.23 | — |
| SECONDARY Relative Perihematomal Edema Volume |
0.96; 1.23 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- supratentorial hematomas confirmed by admitted cranial computed tomography (CT), with the volume ranging from 10 to 30 mL;
- age 18-80 years;
- National Institute of Health Stroke Scale (NIHSS) ≥ 6 and Glasgow Coma Scale (GCS) > 8 at admission;
- onset-to-enrollment time ≤ 24 h;
- signed informed consent.
Exclusion criteria
- a history of ICH, ischemic attack, brain tumor, brain trauma, and other intracranial injury or disorders;
- pre-stroke modified ranking scales (mRS) ≥ 1;
- life-threatening condition;
- pre-stroke complicated with austere diseases such as cancer, heart failure, and respiratory failures;
- severe liver and kidney disorders;
- a history of respiratory diseases;
- poor compliance;
- participation in other clinical trials within the previous three months.
Data sourced from ClinicalTrials.gov (NCT04144868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.