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HBO After Thrombectomy for AIS With LVO

2. juni 2026 oppdatert av: Beijing Tiantan Hospital

HyperBaric Oxygen Therapy After ACute Thrombectomy in Acute Ischemic strOke Due to Large Vessel occlusioN

The purpose of this RCT trial is to evaluate whether the sequential hyperbaric oxygen therapy can improve the 90-day functional outcome in patients with acute large vessel occlusion ischemic stroke after endovascular treatment.

Studieoversikt

Detaljert beskrivelse

This is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial with a 1:1 ratio, comparing the effect of hyperbaric oxygen therapy plus standard medical treatment versus standard medical treatment alone after endovascular treatment in patients with acute large vessel occlusion ischemic stroke. The primary outcome is modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization.

Studietype

Intervensjonell

Registrering (Antatt)

420

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100071
        • Rekruttering
        • Beijing Tiantan Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Age 18~80 years;
  2. Clinically diagnosed as acute large vessel occlusive ischemic stroke, suitable for and received endovascular treatment according to current clinical guidelines;
  3. The onset of stroke or the last normal time to the time of endovascular treatment ≤ 24 hours;
  4. Pre-stroke mRS score of 0 or 1;
  5. Baseline NIHSS score before endovascular treatment ≥ 6 points in the anterior circulation or ≥10 points in the posterior circulation;
  6. CTA, MRA, or DSA angiography before endovascular treatment confirmed occlusion of large vessels (internal carotid artery, middle cerebral artery M1 segment, basilar artery), consistent with symptoms and signs;
  7. The corresponding anterior circulation ASPECTS score or posterior circulation pc-ASPECTS score ≥ 6 points;
  8. The pontine midbrain index (PMI) of patients with acute basilar artery occlusion ≤3;
  9. Patients or their family members sign the informed consent form.

Exclusion Criteria:

  1. Patients with extensive bleeding or severe increase in infarct area, midline displacement (>0.5cm), etc. during endovascular treatment, who plan to undergo bone valve decompression or ventricular drainage;
  2. Known bleeding risk factors, including coagulation factor deficiency, or receiving anticoagulant therapy, INR>3.0 or APTT > 3 times normal or platelet count less than 50×10⁹/L;
  3. Severe hepatic or renal dysfunction (severe hepatic dysfunction refers to ALT or AST > 3 times the upper limit of the normal range, severe renal dysfunction refers to serum creatinine Cr >1.5 times the upper limit of the normal range);
  4. Females of pregnancy, or positive pregnancy test prior to randomization;
  5. Severe persistent and medication-uncontrollable hypertension (systolic blood > 185 mmHg or diastolic blood > 110 mmHg)
  6. Baseline blood glucose of <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L);
  7. The oxygen required to maintain 95% of peripheral arterial oxygen saturation (SaO2) under the current medium-term management guidelines > 3L/min;
  8. End-stage disease other than the nervous system, life expectancy < 90 days;
  9. Participating in other drug or medical device clinical trials;
  10. CT or MR suggests intracranial tumors (other than meningiomas) or other high-risk intracranial vascular malformations;
  11. Patients with anemia, polycythemia or other conditions requiring urgent oxygen;
  12. Unable to cooperate with hyperbaric oxygen therapy, or have other diseases that are not suitable for hyperbaric oxygen therapy (such as active/chronic obstructive pulmonary disease, acute respiratory distress syndrome, tension pneumothorax, tension pneumocephalus, etc.).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard medisinsk behandling
According to the current guideline "2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association" "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023", they receive standard medical treatment and monitoring (including antithrombotic drugs, lipid-lowering drugs, blood pressure management, etc.), not entering the hyperbaric oxygen chamber for treatment.
Andre navn:
  • medisinsk behandling
Eksperimentell: Hyperbaric oxygen therapy+ standard medical treatment

The first treatment was initiated within 24 hours after enrollment. The treatment plan is: in a medical multi-person air pressurized chamber, the treatment pressure is 0.2 MPa, the pressurization time is 30 minutes, the mask inhales 100% oxygen for 60 minutes, and the decompression time is 30 minutes. Once a day, once on the 1st, 2nd, and 3rd days after enrollment (i.e., within the 24-hour, 48-hour, and 72-hour time window), a total of 3 times. Vital signs such as blood pressure, heart rate, and blood oxygen saturation will be monitored before, during, and after each hyperbaric oxygen therapy.

The rest of the treatment is standard medical treatment and monitoring according to the current clinical guideline "2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association" "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023".

Andre navn:
  • HBO

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
mRS score distribution at 90 days
Tidsramme: 90±14 days after randomization
Modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization
90±14 days after randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
mRS score 0-1 at 90 days after randomization
Tidsramme: 90±14 days after randomization
90±14 days after randomization
mRS score 0-2 at 90 days after randomization
Tidsramme: 90±14 days after randomization
90±14 days after randomization
Change in NIHSS score from baseline to 24 hours postoperatively
Tidsramme: 24 hours after endovascular treatment
24 hours after endovascular treatment
Change in NIHSS score from baseline to 5 days postoperatively (after the end of hyperbaric oxygen therapy)
Tidsramme: 5 days after endovascular treatment
5 days after endovascular treatment
Recanalization rate of responsible arteries at 24-48h postoperatively
Tidsramme: 24-48 hours after endovascular treatment
24-48 hours after endovascular treatment
Volume of cerebral infarction on the 5th postoperative day or at discharge (after the end of hyperbaric oxygen therapy)
Tidsramme: 5 days after endovascular treatment or at discharge
assessed by MRI or CT
5 days after endovascular treatment or at discharge
Total number of days in hospital
Tidsramme: From date of randomization until date of hospital discharge, assessed up to 30 days.
Number of days hospitalized (from randomization to hospital discharge)
From date of randomization until date of hospital discharge, assessed up to 30 days.
Quality of life EQ-5D-5L score at 90 days after randomization
Tidsramme: 90±14 days after randomization
The EuroQoL 5-Dimensions 5-Level (EQ-5D-5L) is a five-dimension, five-level health-related quality of life instrument. Based on the Chinese value set, its utility score ranges from -0.391 to 1.000, with higher scores indicating better outcomes.
90±14 days after randomization
mRS score 0-1 at 1 year after randomization
Tidsramme: 1 year ±30 days after randomization
1 year ±30 days after randomization
mRS score 0-2 at 1 year after randomization
Tidsramme: 1 year ±30 days after randomization
1 year ±30 days after randomization

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause death 90 days after randomization
Tidsramme: 90±14 days after randomization
90±14 days after randomization
Symptomatic intracranial hemorrhage at 18-36 hours after randomization
Tidsramme: 18-36 hours after randomization
Symptomatic intracranial hemorrhage was defined according to the Heidelberg classification of hemorrhage
18-36 hours after randomization
Any type of intracranial hemorrhage at 18-36 hours after randomization
Tidsramme: 18-36 hours after randomization
confirmed by CT or MRI images
18-36 hours after randomization

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ning Ma, MD, Beijing Tiantan Hospital
  • Hovedetterforsker: Qiuhong Yu, MD, Beijing Tiantan Hospital
  • Hovedetterforsker: Yuesong Pan, MD, Beijing Tiantan Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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