Primary decompressive craniectomy in aneurysmal subarachnoid hemorrhage - PICASSO

Klinik und Poliklinik für Neurochirurgie0 个研究点目标入组 57 人开始时间: 2019年9月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Subjects will only be included in the study if they meet all of the fol-lowing criteria:
•- Male or female subjects, age = 18 years and = 80 years old
•- Aneurysmal subarachnoid hemorrhage
•- WFNS (grading system used to classify the severity of a sub-arachnoid hemorrhage based on the patients initial clinical condi-tion) grade 4 or 5 at admission
•- Operation can be performed within the first 24 hours after symp-toms of hemorrhage have started
•- Early aneurysm treatment must be deemed possible in order to perform primary decompressive craniectomy within 24h after symptoms of hemorrhage have started if randomized in arm A.

•Subjects will not be included in the study if any of the following criteria applies:
•- Moribund patient (before subarachnoid hemorrhage) due to other illness
•- SAH due to any other cause than aneurysm rupture (traumatic, arteriovenous malformation (AVM), fistula, dissection)
•- Patients with foreseeable difficulties to perform the follow-up adequatelyin
•- Strong indication of inability (before aSAH) to understand and respond to questions in German
•- Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
•- Patients with obvious evidence of irreparable brainstem or thalamic injury

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