Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Early surgery may save lives in severe stroke patients

NCT ID NCT07118345

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether performing skull surgery early, before dangerous brain swelling occurs, can improve outcomes for people who have had a severe stroke and are at high risk of swelling. About 380 adults aged 18–75 will be randomly assigned to receive either early surgery plus standard care or standard care alone. The goal is to see if early surgery helps more people survive with less disability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Premorbid mRS ≤1; 2. Time from symptom onset to puncture ≤24 hours; including wake-up stroke and unwitnessed stroke. The time at which symptoms began was defined as the "Last Known Well" (LKW). 3.18 to 75 years of age; 4.Internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA). Patients with involvement of ipsilateral anterior cerebral artery (ACA), MCA or embryonal posterior cerebral artery (PCA) are eligible for inclusion. 5.NIHSS1a ≥ 1 (with the clarification that changes in alertness cannot be attributable to cerebral edema); 6.Meeting any of the following criteria: 1. ASPECTS 3-5 and NIHSS ≥ 30; 2. ASPECTS 0-2; 7.Signs on CT/MRI of an infarct of at least 50% of the middle cerebral artery territory; 8.No midline shift or midline shift \<5mm; 9.Mechanical Thrombectomy and successful recanalization (defined as eTICI ≥2b50); 10.Ability to initiate decompressive hemicraniectomy within 6 hours after completion of mechanical thrombectomy and within 4 hours after randomization; 11.Informed consent obtained from the patient or his/her legal representative. Exclusion Criteria: Clinical Exclusion Criteria 1. Any symptoms and signs of brain herniation before randomization, such as pupil anisocoria and unstable vital signs. 2. In the judgment of the investigator, the subject is likely to have supportive care withdrawn in the first day. 3. Commitment to decompressive hemicraniectomy (DHC) prior to enrollment. 4. Severe, sustained hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 110 mm Hg); 5. Baseline blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L); 6. Baseline platelet count \<100 x10\^9/L; 7. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with international normalized ratio \> 1.7; 8. Severe renal insufficiency, defined as serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate \[GFR\] \< 30 ml/min, or patients requiring hemodialysis or peritoneal dialysis; 9. Patients that cannot complete 90-day follow-up (such as no fixed residence, overseas patients, etc.); 10. Suspected vasculitis or septic embolism; 11. Neurological diseases or mental disorders before onset that affect the assessment of the condition; 12. Females who are pregnant or in lactation; 13. Participating in other clinical trials that could confound the evaluation of the study; 14. Subjects who, in the opinion of the investigator, have a life expectancy \<3 months due to conditions not related to current LHI or are unlikely to comply with follow-up requirements. Other conditions that the investigators believe are not suitable for participation or may pose a significant risk to the patient. Neuroimaging Exclusion Criteria 1. Evidence of other brain diseases such as cerebral trauma, intracranial tumor (except small meningioma), cerebral aneurysm, etc. 2. Evidence of acute ischemic infarction in bilateral anterior circulation territory or involvement of posterior circulation territories (other than in patients with a fetal or near-fetal PCA configuration); 3. Vascular perforation during thrombectomy; 4. The pre-randomization CT findings exhibits evidence of parenchymal hemorrhage 2 intracranial hemorrhage, diffuse severe subarachnoid hemorrhage, or intraventricular hemorrhage. Patients with localized mild subarachnoid hemorrhage, hemorrhagic infarction type1 or 2, and small parenchymal hematoma type 1 without midline shift may be included;

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute ischemic stroke due to anterior circulation large vessel occlusion are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Liaocheng Brain Hospital

    RECRUITING

    Shandong, China

  • Xuanwu Hospital, Capital Medical University.

    NOT_YET_RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.