HBO After Thrombectomy for AIS With LVO

NCT07626450 | Recruiting DMC

• 1 other identifier: BTH-HBO ACTION
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

Hyperbaric Oxygen Therapy; Thrombectomy; Acute ischemic stroke; Large vessel occlusion

Outcome Measures

Primary Outcomes (1)

• mRS score distribution at 90 days

  Modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization

  90±14 days after randomization

Secondary Outcomes (10)

• mRS score 0-1 at 90 days after randomization

  90±14 days after randomization

• mRS score 0-2 at 90 days after randomization

  90±14 days after randomization

• Change in NIHSS score from baseline to 24 hours postoperatively

  24 hours after endovascular treatment

• Change in NIHSS score from baseline to 5 days postoperatively (after the end of hyperbaric oxygen therapy)

  5 days after endovascular treatment

• Recanalization rate of responsible arteries at 24-48h postoperatively

  24-48 hours after endovascular treatment

Other Outcomes (3)

• All-cause death 90 days after randomization

  90±14 days after randomization

• Symptomatic intracranial hemorrhage at 18-36 hours after randomization

  18-36 hours after randomization

• Any type of intracranial hemorrhage at 18-36 hours after randomization

  18-36 hours after randomization

Study Arms (2)

Hyperbaric oxygen therapy+ standard medical treatment

EXPERIMENTAL

Other: Hyperbaric oxygen therapy plus standard medical treatment

Standard medical treatment

ACTIVE COMPARATOR

Other: Standard medical treatment

Interventions

Standard medical treatment OTHER

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.

Also known as: medical treatment

Standard medical treatment

Hyperbaric oxygen therapy plus standard medical treatment OTHER

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".

Also known as: HBO

Hyperbaric oxygen therapy+ standard medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 41582814 BACKGROUND

• 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.

  PMID: 26898852 BACKGROUND

• 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.

  PMID: 33596674 BACKGROUND

• 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.

  PMID: 39922675 BACKGROUND

• 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.

  PMID: 33410112 BACKGROUND

• 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.

  PMID: 26859390 BACKGROUND

• 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.

  PMID: 41583503 BACKGROUND

• 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.

  PMID: 39271781 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 40534750 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Ning Ma, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Qiuhong Yu, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Yuesong Pan, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Ma, MD

CONTACT

13581889908; maning_03@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)