Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke

NCT06801457 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: AN-O2-EMS
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.

Conditions

Stroke Acute

Keywords

Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Level of disability at 90 days measured by modified Rankin scale (mRS) score

  The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome; the primary outcome here is 3-month ordinal mRS score with mRS 5 and 6 merged into one category; modified intention-to-treat analysis

  90 days after randomization

Secondary Outcomes (7)

• Functional independence at 90 days defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up

  90 days after randomization

• Excellent functional outcome at 90 days, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up

  90 days after randomization

• National Institutes of Health Stroke Scale (NIHSS) obtained obtained upon Endovascular Thrombectomy (EVT) site arrival

  Day 0

• National Institutes of Health Stroke Scale (NIHSS) obtained at 24 hours

  24 hours after randomization

• ASPECTS on admission head CT

  Day 0

Other Outcomes (9)

• Serious adverse events/Adverse events

  Through study completion

• Symptomatic intracranial hemorrhage

  Up to 36 hours after randomization

• Any intracranial hemorrhage

  Up to 36 hours after randomization

Study Arms (2)

NBO

EXPERIMENTAL

NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice.

Other: NBO

Control

OTHER

Best medical treatment

Other: Control

Interventions

NBO OTHER

NBO will be conducted with inhalation of 100% oxygen.

NBO

Control OTHER

Best medical care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years old;
• Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
• No prior stroke;
• The time from stroke onset/last seen well to randomization is within 6 hours;
• Paramedic-obtained FAST-ED score \>= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
• No significant pre-stroke disability (pre-stroke mRS 0-1);
• Signed informed consent from the patient or the legally authorized representative (LAR).

You may not qualify if:

• Endotracheal intubation in the field (prior to consent);
• Respiratory rate \<= 10 or \>= 30 breaths per minute;
• Oxygen-dependence at baseline to maintain SaO2 \> 95%;
• Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
• Seizure at stroke onset;
• Exhibiting symptoms of vomiting, severe headache, or unconscious;
• Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
• Participating in another clinical trial, or completed participation within prior 30 days;
• Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
• Life expectancy \< 90 days due to comorbidities;
• Unlikely to complete the 90-day follow-up visit.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Lan Liu, PhD

CONTACT

8683911991; liulan1815@outlook.com

Wenbo Hu, MD

CONTACT

8683911991; huwenbo0050@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 30, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

CN (1)