HBO After Thrombectomy for AIS With LVO

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke From Large Vessel Occlusion
• Intervention / Treatment: Other: Hyperbaric oxygen therapy plus standard medical treatment; Other: Standard medical treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Ma, MD; Phone Number: 13581889908; Email: maning_03@hotmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100071
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Ning Ma, MD; Phone Number: 13581889908; Email: maning_03@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard medical treatment	Other: Standard medical treatment; 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.; Other Names: medical treatment
Experimental: Hyperbaric oxygen therapy+ standard medical treatment	Other: Hyperbaric oxygen therapy plus 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".; Other Names: HBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Volume of cerebral infarction on the 5th postoperative day or at discharge (after the end of hyperbaric oxygen therapy)	assessed by MRI or CT	5 days after endovascular treatment or at discharge
Total number of days in hospital	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	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		1 year ±30 days after randomization
mRS score 0-2 at 1 year after randomization		1 year ±30 days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death 90 days after randomization		90±14 days after randomization
Symptomatic intracranial hemorrhage at 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	confirmed by CT or MRI images	18-36 hours after randomization

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Ning Ma, MD, Beijing Tiantan Hospital; Principal Investigator: Qiuhong Yu, MD, Beijing Tiantan Hospital; Principal Investigator: Yuesong Pan, MD, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Thrombectomy; Acute ischemic stroke; Hyperbaric Oxygen Therapy; Large vessel occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Therapeutics; Respiratory Therapy; Oxygen Inhalation Therapy; Hyperbaric Oxygenation
• Other Study ID Numbers: BTH-HBO ACTION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No