Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke

Not yet recruitingOBSERVATIONAL
Enrollment

356

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

March 30, 2027

Study Completion Date

May 30, 2027

Conditions
Ischemic Stroke, AcuteMalignant Cerebral Edema
Interventions
PROCEDURE

Expansion-floating Craniotomy

Following craniotomy with bone flap removal, cerebral edema is assessed. The bone flap is then elevated using 2-3 titanium connectors. The elevation height must be sufficient to at least prevent contact between the bone flap and the underlying brain tissue. If cerebral swelling proves less severe than anticipated or begins to subside, the connectors can be loosened minimally invasively after a maximum scalp expansion period of 7-10 days. The elevated bone flap gradually repositions itself. Mild compression is applied using an elastic bandage for fixation, thereby restoring cranial integrity.

PROCEDURE

decompressive craniectomy

The patient is placed supine with the head rotated contralaterally. A large retroauricular question-mark incision is made in the scalp. Alternatively, a Kempe incision or preauricular incision may be used according to surgeon preference. Meticulous preservation of the superficial temporal artery (STA) is essential during the procedure to prevent ischemic complications in the flap. After elevating the myocutaneous flap to expose the operative field, a fronto-temporo-parietal craniectomy is performed. For unilateral decompressive craniectomy, the bone window should measure at least 15 × 12 cm, extending inferiorly to the floor of the temporal fossa to ensure adequate decompression.

DRUG

drug conservative therapeutic

Pharmacotherapy for malignant cerebral edema has been implemented according to current guidelines.

All Listed Sponsors
lead

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

NCT07195786 - Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke | Biotech Hunter | Biotech Hunter