HBO After Thrombectomy for AIS With LVO

ConditionAcute Ischemic Stroke From Large Vessel Occlusion

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Hyperbaric oxygen therapy plus standard medical treatment
Other intervention
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".
Standard medical treatment
Other intervention
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.

Treatment groups

420 Participants

are divided into 2 treatment groups

Group A: Hyperbaric oxygen therapy+ standard medical treatmentExperimental treatment 1 intervention

Group B: Standard medical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

mRS score distribution at 90 days

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

Time frame

90±14 days after randomization

Secondary outcomes

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

Other outcomes

All-cause death 90 days after randomization

Time frame

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

Time frame

18-36 hours after randomization

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

confirmed by CT or MRI images

Time frame

18-36 hours after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

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