Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury

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Enrollment

292

Participants

Timeline

Start Date

July 8, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2027

Conditions
Traumatic Brain InjuriesIntracranial Hypertension
Interventions
PROCEDURE

Decompressive Craniectomy

"The DC will be performed through a standard trauma incision, a retro-auricular C-shape or a Kempe incision and execute a 15x15 cm craniotomy with a C-shape durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. There are multiple techniques for DC. The elected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal DC will be considered. The removed bone flap may be stored in an abdominal pouch in the right or left upper abdominal quadrants or by freezing in a bone or blood bank freezer."

PROCEDURE

Expansion Craniotomy

"The EC will be performed through a retro-auricular C-shape incision and executing a 15x15 cm craniotomy with a C-shape durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. The expansion craniotomy will be finished with a cranioplasty using a full set of 3-5 Rialto plates for bone graft closure. The selected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal EC will be considered."

Sponsors
All Listed Sponsors
lead

Meditech Foundation

OTHER