- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07626450
HBO After Thrombectomy for AIS With LVO
HyperBaric Oxygen Therapy After ACute Thrombectomy in Acute Ischemic strOke Due to Large Vessel occlusioN
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ning Ma, MD
- Número de teléfono: 13581889908
- Correo electrónico: maning_03@hotmail.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100071
- Reclutamiento
- Beijing Tiantan Hospital
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Contacto:
- Ning Ma, MD
- Número de teléfono: 13581889908
- Correo electrónico: maning_03@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Tratamiento médico estándar
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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.
Otros nombres:
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Experimental: 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".
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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mRS score distribution at 90 days
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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mRS score 0-1 at 90 days after randomization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year ±30 days after randomization
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1 year ±30 days after randomization
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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All-cause death 90 days after randomization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ning Ma, MD, Beijing Tiantan Hospital
- Investigador principal: Qiuhong Yu, MD, Beijing Tiantan Hospital
- Investigador principal: Yuesong Pan, MD, Beijing Tiantan Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Carrera
- Accidente cerebrovascular isquémico
- Terapéutica
- Terapia respiratoria
- Terapia con inhalación de oxígeno
- Oxigenación hiperbárica
Otros números de identificación del estudio
- BTH-HBO ACTION
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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