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The AGAINST Protocol: Augmentative Craniotomy in Stroke

NCT05860855 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-05-16

No results posted yet for this study

Summary

Malignant Middle Cerebral Artery (MCA) infarction is a term used for the severe clinical and neurological hemispheric syndrome caused by ischemic occlusion of the proximal tract of MCA and it is observed in near the 10% of all ischemic strokes.In order to prevent the severe consequences caused by malignant MCA infarction, decompressive hemicraniectomy has been proposed as early intervention against the expected clinical worsening due to endocranial hypertension and several trials demonstrated how it positively affects the mortality and morbidity rates compared to conservative management. However, patients undergoing decompressive hemicraniectomy generally encounter other kinds of complications, related to the consequences of the surgical procedure. With the intent of reducing these complications, alternative decompression techniques have been proposed, such as hinge or floating craniectomy or augmentative craniotomy, in which the bony operculum is left in place. These alternative methods of cranial decompression have been shown to have similar efficacy to standard craniectomy, but comparative trials have never been conducted.In the present protocol, the investigators present a study design that compares the standard decompressive hemicraniectomy to a novel technique of augmentative craniotomy. The rationale of the study is to maintain the important advantages related to brain decompression in malignant MCA infarction while avoiding the complications related to the surgical procedure of hemicraniectomy.

Conditions

  • Middle Cerebral Artery Occlusion With Cerebral Infarction

Interventions

PROCEDURE

Augmentative craniotomy

Expansion of the skull

PROCEDURE

Decompressive craniotomy

Standard hemicraniectomy

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Luigi Valentino Berra · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-10-31
Completion
2024-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05860855 on ClinicalTrials.gov