HBO After Thrombectomy for AIS With LVO

Official title

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

Overview

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.

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.

Interventions

• 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
• 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.

Primary outcome measures

• mRS score distribution at 90 days [Time frame: 90±14 days after randomization]

Secondary outcome measures (10)

• mRS score 0-1 at 90 days after randomization [Time frame: 90±14 days after randomization]
• mRS score 0-2 at 90 days after randomization [Time frame: 90±14 days after randomization]
• Change in NIHSS score from baseline to 24 hours postoperatively [Time frame: 24 hours after endovascular treatment]
• Change in NIHSS score from baseline to 5 days postoperatively (after the end of hyperbaric oxygen therapy) [Time frame: 5 days after endovascular treatment]
• Recanalization rate of responsible arteries at 24-48h postoperatively [Time frame: 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) [Time frame: 5 days after endovascular treatment or at discharge]
• Total number of days in hospital [Time frame: 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 [Time frame: 90±14 days after randomization]
• mRS score 0-1 at 1 year after randomization [Time frame: 1 year ±30 days after randomization]
• mRS score 0-2 at 1 year after randomization [Time frame: 1 year ±30 days after randomization]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Publications

• 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 PMID 41582814
• 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 collaborator PMID 26898852
• 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, PMID 33596674
• 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-cont PMID 39922675
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07626450 · BTH-HBO ACTION

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗