Ischemic stroke
Conditions
Interventions
Trial Group :Cranioplasty with micro-movement + conventional medical therapy. Preoperative preparation begins on day 1 after randomization
craniotomy is performed on day 2 after randomization. Cranioplasty micro-movement begins on postoperative day 4: upward micro-movement for 3 days (1 mm/day), followed by downward micro-movement for 3
Sponsors
The First Hospital of Jilin University.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, regardless of gender; 2. Patients with clinically confirmed ischemic stroke within 14 days of onset and a pre-randomization mRS score >=4; 3. Patients with imaging-confirmed anterior circulation cerebral infarction; 4. Patients or their legal representatives consent to this treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing mechanical thrombectomy after symptom onset; 2. Patients who underwent intracranial surgery within the past 6 months; 3. Patients with atrial fibrillation; 4. Patients with significant intracranial hypertension, such as cerebral edema or hydrocephalus; 5. Patients with a history of intracranial or scalp infection within the past year; 6. Severe consciousness impairment: NIHSS consciousness level score > 1 point; 7. Patients with skull defects; 8. Patients with concomitant major organ failure, tumors, or undergoing antineoplastic therapy; 9. Pregnant or lactating women; 10. Patients with severe psychiatric disorders or other conditions preventing cooperation with data collection; 11. Participation in another clinical trial within 30 days prior to randomization, or current participation in another clinical trial; 12. Other circumstances deemed inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an mRS score of 0-2 at 90 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with an mRS score of 0-2 at 30 days after randomization;The proportion of patients with an mRS score of 0-1 at 90 days after randomization;The distribution of mRS scores at 90 days after randomization;The NIHSS scores between the two groups at 14 days/at discharge after randomization; | — |
Countries
China
Contacts
Public ContactYang Yi
The First Hospital of Jilin University
Outcome results
None listed