Status:
NOT_YET_RECRUITING
Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Ischemic Stroke, Acute
Malignant Cerebral Edema
Eligibility:
All Genders
18-80 years
Brief Summary
This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly ...
Detailed Description
Extensive cerebral infarction leads to progressive brain edema within 24-48 hours of ischemic injury. This edema can cause secondary damage over subsequent days through elevated intracranial pressure ...
Eligibility Criteria
Inclusion
- Age requirement: Adults aged \>18 but \<80 years
- Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria:
- NIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating \>50% MCA territory infarction or hypoperfused area \>2/3, OR DWI hyperintensity volume \>82 ml within 6 hours of onset, OR DWI infarct volume \>145 ml within 14 hours
- Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci/cisterns.
Exclusion
- Pre-stroke mRS score ≥1
- Significant contralateral cerebral infarction
- Symptomatic intracranial hemorrhage
- Any known coagulopathy
- Life expectancy \<3 years
- Any severe comorbidities potentially interfering with treatment evaluation
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT07195786
Start Date
October 1 2025
End Date
May 30 2027
Last Update
September 29 2025
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