- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07626450
HBO After Thrombectomy for AIS With LVO
HyperBaric Oxygen Therapy After ACute Thrombectomy in Acute Ischemic strOke Due to Large Vessel occlusioN
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ning Ma, MD
- Telefonnummer: 13581889908
- E-mail: maning_03@hotmail.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100071
- Rekruttering
- Beijing Tiantan Hospital
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Kontakt:
- Ning Ma, MD
- Telefonnummer: 13581889908
- E-mail: maning_03@hotmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18~80 years;
- Clinically diagnosed as acute large vessel occlusive ischemic stroke, suitable for and received endovascular treatment according to current clinical guidelines;
- The onset of stroke or the last normal time to the time of endovascular treatment ≤ 24 hours;
- Pre-stroke mRS score of 0 or 1;
- Baseline NIHSS score before endovascular treatment ≥ 6 points in the anterior circulation or ≥10 points in the posterior circulation;
- 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;
- The corresponding anterior circulation ASPECTS score or posterior circulation pc-ASPECTS score ≥ 6 points;
- The pontine midbrain index (PMI) of patients with acute basilar artery occlusion ≤3;
- Patients or their family members sign the informed consent form.
Exclusion Criteria:
- 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;
- 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;
- 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);
- Females of pregnancy, or positive pregnancy test prior to randomization;
- Severe persistent and medication-uncontrollable hypertension (systolic blood > 185 mmHg or diastolic blood > 110 mmHg)
- Baseline blood glucose of <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L);
- The oxygen required to maintain 95% of peripheral arterial oxygen saturation (SaO2) under the current medium-term management guidelines > 3L/min;
- End-stage disease other than the nervous system, life expectancy < 90 days;
- Participating in other drug or medical device clinical trials;
- CT or MR suggests intracranial tumors (other than meningiomas) or other high-risk intracranial vascular malformations;
- Patients with anemia, polycythemia or other conditions requiring urgent oxygen;
- 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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Standard medicinsk behandling
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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 navne:
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Eksperimentel: Hyperbaric oxygen therapy+ standard medical treatment
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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 navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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mRS score distribution at 90 days
Tidsramme: 90±14 days after randomization
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Modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization
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90±14 days after randomization
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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mRS score 0-1 at 90 days after randomization
Tidsramme: 90±14 days after randomization
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90±14 days after randomization
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mRS score 0-2 at 90 days after randomization
Tidsramme: 90±14 days after randomization
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90±14 days after randomization
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Change in NIHSS score from baseline to 24 hours postoperatively
Tidsramme: 24 hours after endovascular treatment
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24 hours after endovascular treatment
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Change in NIHSS score from baseline to 5 days postoperatively (after the end of hyperbaric oxygen therapy)
Tidsramme: 5 days after endovascular treatment
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5 days after endovascular treatment
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Recanalization rate of responsible arteries at 24-48h postoperatively
Tidsramme: 24-48 hours after endovascular treatment
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24-48 hours after endovascular treatment
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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
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assessed by MRI or CT
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5 days after endovascular treatment or at discharge
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Total number of days in hospital
Tidsramme: From date of randomization until date of hospital discharge, assessed up to 30 days.
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Number of days hospitalized (from randomization to hospital discharge)
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From date of randomization until date of hospital discharge, assessed up to 30 days.
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Quality of life EQ-5D-5L score at 90 days after randomization
Tidsramme: 90±14 days after randomization
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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.
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90±14 days after randomization
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mRS score 0-1 at 1 year after randomization
Tidsramme: 1 year ±30 days after randomization
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1 year ±30 days after randomization
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mRS score 0-2 at 1 year after randomization
Tidsramme: 1 year ±30 days after randomization
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1 year ±30 days after randomization
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause death 90 days after randomization
Tidsramme: 90±14 days after randomization
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90±14 days after randomization
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Symptomatic intracranial hemorrhage at 18-36 hours after randomization
Tidsramme: 18-36 hours after randomization
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Symptomatic intracranial hemorrhage was defined according to the Heidelberg classification of hemorrhage
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18-36 hours after randomization
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Any type of intracranial hemorrhage at 18-36 hours after randomization
Tidsramme: 18-36 hours after randomization
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confirmed by CT or MRI images
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18-36 hours after randomization
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ning Ma, MD, Beijing Tiantan Hospital
- Ledende efterforsker: Qiuhong Yu, MD, Beijing Tiantan Hospital
- Ledende efterforsker: Yuesong Pan, MD, Beijing Tiantan Hospital
Publikationer og nyttige links
Generelle publikationer
- Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
- Jia B, Ren Z, Mokin M, Burgin WS, Bauer CT, Fiehler J, Mo D, Ma N, Gao F, Huo X, Luo G, Wang A, Pan Y, Song L, Sun X, Zhang X, Gui L, Song C, Peng Y, Wu J, Zhao S, Zhao J, Zhou Z, Li Y, Jing P, Yang L, Liu Y, Zhao Q, Liu Y, Peng X, Gao Q, Guo Z, Chen W, Li W, Cheng X, Xu Y, Zhang Y, Zhang G, Lu Y, Lu X, Wang D, Wang Y, Li H, Ling L, Peng G, Zhang J, Zhang K, Li S, Qi Z, Xu H, Tong X, Ma G, Liu R, Guo X, Deng Y, Leng X, Leung TW, Liebeskind DS, Wang Y, Wang Y, Miao Z; ANGEL-ACT Study Groupdagger. Current Status of Endovascular Treatment for Acute Large Vessel Occlusion in China: A Real-World Nationwide Registry. Stroke. 2021 Apr;52(4):1203-1212. doi: 10.1161/STROKEAHA.120.031869. Epub 2021 Feb 18.
- Prabhakaran S, Gonzalez NR, Zachrison KS, Adeoye O, Alexandrov AW, Ansari SA, Chapman S, Czap AL, Dumitrascu OM, Ishida K, Jadhav AP, Johnson B, Johnston KC, Khatri P, Kimberly WT, Lee VH, Leslie-Mazwi TM, Mac Grory B, Madsen TE, Menon B, Mistry EA, Park S, Parker S, Perez de la Ossa N, Reeves M, Saiz T, Scott PA, Schwartzberg D, Sheth SA, Sporns PB, Times S, Tjoumakaris S, Wolfe SQ, Yaghi S; Peer Review Committee. 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2026 Jan 26. doi: 10.1161/STR.0000000000000513. Online ahead of print.
- Li W, Lan J, Wei M, Liu L, Hou C, Qi Z, Li C, Jiao L, Yang Q, Chen W, Liu S, Yue X, Dong Q, Yuan H, Gao Z, Wu X, Wen C, Li T, Jiang C, Li D, Chen Z, Shi J, Shi W, Yuan J, Qin Y, Li B, Fisher M, Feng W, Liu KJ, Ji X; OPENS-2 Investigators. Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial. Lancet. 2025 Feb 8;405(10477):486-497. doi: 10.1016/S0140-6736(24)02809-5.
- Cheng Z, Geng X, Tong Y, Dornbos D 3rd, Hussain M, Rajah GB, Gao J, Ma L, Li F, Du H, Fisher M, Ding Y. Adjuvant High-Flow Normobaric Oxygen After Mechanical Thrombectomy for Anterior Circulation Stroke: a Randomized Clinical Trial. Neurotherapeutics. 2021 Apr;18(2):1188-1197. doi: 10.1007/s13311-020-00979-3. Epub 2021 Jan 6.
- Xu Y, Ji R, Wei R, Yin B, He F, Luo B. The Efficacy of Hyperbaric Oxygen Therapy on Middle Cerebral Artery Occlusion in Animal Studies: A Meta-Analysis. PLoS One. 2016 Feb 9;11(2):e0148324. doi: 10.1371/journal.pone.0148324. eCollection 2016.
- Huang Y, Liu X, Yang X, Zhang S. Neuroprotective Mechanisms of Hyperbaric Oxygen Therapy in Cerebral Ischemia-Hypoxia Injury Following Cardiopulmonary Resuscitation. Int J Med Sci. 2026 Jan 14;23(2):670-683. doi: 10.7150/ijms.123862. eCollection 2026.
- Guo Y, Liu J, Du X, Qi M, She T, Xue K, Wu X, Xu L, Peng B, Zhang Y, Liu Y, Jiang Z, Li X, Yuan Y. ROS exhaustion reverses the effects of hyperbaric oxygen on hemorrhagic transformation through reactivating microglia in post-stroke hyperglycemic mice. Sci Rep. 2024 Sep 13;14(1):21410. doi: 10.1038/s41598-024-72454-4.
- Hussein O, Sawalha K, Elazim A, et al. Hyperbaric oxygen therapy after acute ischemic stroke with large penumbra: a case report. The Egyptian Journal of Neurology Psychiatry and Neurosurgery. 2020.
- Zhou M, Chen X, Li D, Luo J, Song S, You J, Ma H, Huang C. Bibliometric analysis of research trends on hyperbaric oxygen therapy in stroke from 2000 to 2022. Front Neurol. 2025 Jun 4;16:1455545. doi: 10.3389/fneur.2025.1455545. eCollection 2025.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BTH-HBO ACTION
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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